THE OFFICIAL PATIENT’S SOURCEBOOK
on
INTRAOCULAR MELANOMA J AMES N. P ARKER , M.D. AND P HILIP M. P ARKER , P H .D., E DITORS
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ICON Health Publications ICON Group International, Inc. 4370 La Jolla Village Drive, 4th Floor San Diego, CA 92122 USA Copyright Ó2002 by ICON Group International, Inc. Copyright Ó2002 by ICON Group International, Inc. All rights reserved. This book is protected by copyright. No part of it may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without written permission from the publisher. Printed in the United States of America. Last digit indicates print number: 10 9 8 7 6 4 5 3 2 1
Publisher, Health Care: Tiffany LaRochelle Editor(s): James Parker, M.D., Philip Parker, Ph.D. Publisher’s note: The ideas, procedures, and suggestions contained in this book are not intended as a substitute for consultation with your physician. All matters regarding your health require medical supervision. As new medical or scientific information becomes available from academic and clinical research, recommended treatments and drug therapies may undergo changes. The authors, editors, and publisher have attempted to make the information in this book up to date and accurate in accord with accepted standards at the time of publication. The authors, editors, and publisher are not responsible for errors or omissions or for consequences from application of the book, and make no warranty, expressed or implied, in regard to the contents of this book. Any practice described in this book should be applied by the reader in accordance with professional standards of care used in regard to the unique circumstances that may apply in each situation, in close consultation with a qualified physician. The reader is advised to always check product information (package inserts) for changes and new information regarding dose and contraindications before taking any drug or pharmacological product. Caution is especially urged when using new or infrequently ordered drugs, herbal remedies, vitamins and supplements, alternative therapies, complementary therapies and medicines, and integrative medical treatments. Cataloging-in-Publication Data Parker, James N., 1961Parker, Philip M., 1960The Official Patient’s Sourcebook on Intraocular Melanoma: A Revised and Updated Directory for the Internet Age/James N. Parker and Philip M. Parker, editors p. cm. Includes bibliographical references, glossary and index. ISBN: 0-597-83354-0 1. Intraocular Melanoma-Popular works. I. Title.
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Disclaimer This publication is not intended to be used for the diagnosis or treatment of a health problem or as a substitute for consultation with licensed medical professionals. It is sold with the understanding that the publisher, editors, and authors are not engaging in the rendering of medical, psychological, financial, legal, or other professional services. References to any entity, product, service, or source of information that may be contained in this publication should not be considered an endorsement, either direct or implied, by the publisher, editors or authors. ICON Group International, Inc., the editors, or the authors are not responsible for the content of any Web pages nor publications referenced in this publication.
Copyright Notice If a physician wishes to copy limited passages from this sourcebook for patient use, this right is automatically granted without written permission from ICON Group International, Inc. (ICON Group). However, all of ICON Group publications are copyrighted. With exception to the above, copying our publications in whole or in part, for whatever reason, is a violation of copyright laws and can lead to penalties and fines. Should you want to copy tables, graphs or other materials, please contact us to request permission (e-mail:
[email protected]). ICON Group often grants permission for very limited reproduction of our publications for internal use, press releases, and academic research. Such reproduction requires confirmed permission from ICON Group International Inc. The disclaimer above must accompany all reproductions, in whole or in part, of this sourcebook.
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Dedication To the healthcare professionals dedicating their time and efforts to the study of intraocular melanoma.
Acknowledgements The collective knowledge generated from academic and applied research summarized in various references has been critical in the creation of this sourcebook which is best viewed as a comprehensive compilation and collection of information prepared by various official agencies which directly or indirectly are dedicated to intraocular melanoma. All of the Official Patient’s Sourcebooks draw from various agencies and institutions associated with the United States Department of Health and Human Services, and in particular, the Office of the Secretary of Health and Human Services (OS), the Administration for Children and Families (ACF), the Administration on Aging (AOA), the Agency for Healthcare Research and Quality (AHRQ), the Agency for Toxic Substances and Disease Registry (ATSDR), the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the Healthcare Financing Administration (HCFA), the Health Resources and Services Administration (HRSA), the Indian Health Service (IHS), the institutions of the National Institutes of Health (NIH), the Program Support Center (PSC), and the Substance Abuse and Mental Health Services Administration (SAMHSA). In addition to these sources, information gathered from the National Library of Medicine, the United States Patent Office, the European Union, and their related organizations has been invaluable in the creation of this sourcebook. Some of the work represented was financially supported by the Research and Development Committee at INSEAD. This support is gratefully acknowledged. Finally, special thanks are owed to Tiffany LaRochelle for her excellent editorial support.
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About the Editors James N. Parker, M.D. Dr. James N. Parker received his Bachelor of Science degree in Psychobiology from the University of California, Riverside and his M.D. from the University of California, San Diego. In addition to authoring numerous research publications, he has lectured at various academic institutions. Dr. Parker is the medical editor for the Official Patient’s Sourcebook series published by ICON Health Publications.
Philip M. Parker, Ph.D. Philip M. Parker is the Eli Lilly Chair Professor of Innovation, Business and Society at INSEAD (Fontainebleau, France and Singapore). Dr. Parker has also been Professor at the University of California, San Diego and has taught courses at Harvard University, the Hong Kong University of Science and Technology, the Massachusetts Institute of Technology, Stanford University, and UCLA. Dr. Parker is the associate editor for the Official Patient’s Sourcebook series published by ICON Health Publications.
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About ICON Health Publications In addition to intraocular melanoma, Official Patient’s Sourcebooks are available for the following related topics: ·
The Official Patient's Sourcebook on Melanoma
To discover more about ICON Health Publications, simply check with your preferred online booksellers, including Barnes & Noble.com and Amazon.com which currently carry all of our titles. Or, feel free to contact us directly for bulk purchases or institutional discounts: ICON Group International, Inc. 4370 La Jolla Village Drive, Fourth Floor San Diego, CA 92122 USA Fax: 858-546-4341 Web site: www.icongrouponline.com/health
Contents vii
Table of Contents INTRODUCTION...................................................................................... 1
Overview............................................................................................................... 1 Organization......................................................................................................... 3 Scope ..................................................................................................................... 3 Moving Forward................................................................................................... 5
PART I: THE ESSENTIALS ................................................. 7 CHAPTER 1. THE ESSENTIALS ON INTRAOCULAR MELANOMA: GUIDELINES ........................................................................................... 9
Overview............................................................................................................... 9 What Is Intraocular Melanoma? ........................................................................ 11 Stages of Intraocular Melanoma......................................................................... 12 How Is Intraocular Melanoma Treated? ............................................................ 13 Treatment by Stage............................................................................................. 14 To Learn More .................................................................................................... 16 About PDQ......................................................................................................... 17 More Guideline Sources ..................................................................................... 18 Vocabulary Builder............................................................................................. 24
CHAPTER 2. SEEKING GUIDANCE ....................................................... 27
Overview............................................................................................................. 27 Associations and Intraocular Melanoma............................................................ 27 Cancer Support Groups...................................................................................... 29 The Cancer Information Service ......................................................................... 31 Finding Cancer Resources in Your Community................................................ 34 Finding Doctors Who Specialize in Cancer Care ............................................... 37 Selecting Your Doctor ........................................................................................ 40 Working with Your Doctor ................................................................................ 41 Finding a Cancer Treatment Facility ................................................................. 42 Additional Cancer Support Information ............................................................ 44 Vocabulary Builder............................................................................................. 44
CHAPTER 3. CLINICAL TRIALS AND INTRAOCULAR MELANOMA ..... 47
Overview............................................................................................................. 47 Recent Trials on Intraocular Melanoma ............................................................ 50 Benefits and Risks............................................................................................... 70 Clinical Trials and Insurance Coverage ............................................................. 73 Clinical Trials and Medicare Coverage .............................................................. 76 Increasing the Likelihood of Insurance Coverage for Trials ............................... 77 If Your Insurance Claim Is Denied after the Trial Has Begun .......................... 79 Government Initiatives to Expand Insurance Coverage for Trials .................... 82 Keeping Current on Clinical Trials.................................................................... 83 General References.............................................................................................. 84
viii Contents
Vocabulary Builder............................................................................................. 85
PART II: ADDITIONAL RESOURCES AND ADVANCED MATERIAL.................................................. 89 CHAPTER 4. STUDIES ON INTRAOCULAR MELANOMA ....................... 91
Overview............................................................................................................. 91 Federally Funded Research on Intraocular Melanoma....................................... 91 The National Library of Medicine: PubMed ...................................................... 93 Vocabulary Builder........................................................................................... 102
CHAPTER 5. BOOKS ON INTRAOCULAR MELANOMA ....................... 105
Overview........................................................................................................... 105 The National Library of Medicine Book Index ................................................. 105 Chapters on Intraocular Melanoma.................................................................. 106 General Home References ................................................................................. 106 Vocabulary Builder........................................................................................... 107
CHAPTER 6. PHYSICIAN GUIDELINES AND DATABASES ................... 109
Overview........................................................................................................... 109 NIH Guidelines................................................................................................. 109 What Is Intraocular Melanoma? ...................................................................... 110 Cellular Classification ...................................................................................... 111 Stage Information ............................................................................................. 111 Treatment Option Overview ............................................................................ 113 NIH Databases.................................................................................................. 121 Other Commercial Databases ........................................................................... 125 The Genome Project and Intraocular Melanoma ............................................. 126 Specialized References....................................................................................... 130 Vocabulary Builder........................................................................................... 131
PART III. APPENDICES .................................................. 133 APPENDIX A. RESEARCHING YOUR MEDICATIONS.......................... 135
Overview........................................................................................................... 135 Your Medications: The Basics .......................................................................... 136 Learning More about Your Medications .......................................................... 138 Commercial Databases...................................................................................... 139 Drug Development and Approval .................................................................... 140 Understanding the Approval Process for New Cancer Drugs......................... 141 The Role of the Federal Drug Administration (FDA)...................................... 142 Getting Drugs to Patients Who Need Them .................................................... 145 Contraindications and Interactions (Hidden Dangers) ................................... 147 A Final Warning .............................................................................................. 148 General References............................................................................................ 149
APPENDIX B. FINDING MEDICAL LIBRARIES .................................... 151
Overview........................................................................................................... 151
Contents
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Preparation ....................................................................................................... 151 Finding a Local Medical Library ...................................................................... 152 Medical Libraries Open to the Public............................................................... 152
APPENDIX C. YOUR RIGHTS AND INSURANCE ................................. 159
Overview........................................................................................................... 159 Your Rights as a Patient................................................................................... 159 Patient Responsibilities .................................................................................... 163 Choosing an Insurance Plan............................................................................. 164 Medicare and Medicaid .................................................................................... 166 Financial Assistance for Cancer Care............................................................... 169 NORD’s Medication Assistance Programs ..................................................... 172 Additional Resources ........................................................................................ 173 Vocabulary Builder........................................................................................... 173
ONLINE GLOSSARIES.................................................... 175 Online Dictionary Directories.......................................................................... 176
INTRAOCULAR MELANOMA GLOSSARY.............. 177 General Dictionaries and Glossaries ................................................................ 185
INDEX................................................................................... 188
Introduction
1
INTRODUCTION Overview Dr. C. Everett Koop, former U.S. Surgeon General, once said, “The best prescription is knowledge.”1 The Agency for Healthcare Research and Quality (AHRQ) of the National Institutes of Health (NIH) echoes this view and recommends that every patient incorporate education into the treatment process. According to the AHRQ: Finding out more about your condition is a good place to start. By contacting groups that support your condition, visiting your local library, and searching on the Internet, you can find good information to help guide your treatment decisions. Some information may be hard to find—especially if you don’t know where to look.2 As the AHRQ mentions, finding the right information is not an obvious task. Though many physicians and public officials had thought that the emergence of the Internet would do much to assist patients in obtaining reliable information, in March 2001 the National Institutes of Health issued the following warning: The number of Web sites offering health-related resources grows every day. Many sites provide valuable information, while others may have information that is unreliable or misleading.3
Quotation from http://www.drkoop.com. The Agency for Healthcare Research and Quality (AHRQ): http://www.ahcpr.gov/consumer/diaginfo.htm. 3 Adapted from the NIH, National Cancer Institute (NCI): http://cancertrials.nci.nih.gov/beyond/evaluating.html. 1 2
2
Intraocular Melanoma
Since the late 1990s, physicians have seen a general increase in patient Internet usage rates. Patients frequently enter their doctor’s offices with printed Web pages of home remedies in the guise of latest medical research. This scenario is so common that doctors often spend more time dispelling misleading information than guiding patients through sound therapies. The Official Patient’s Sourcebook on Intraocular Melanoma has been created for patients who have decided to make education and research an integral part of the treatment process. The pages that follow will tell you where and how to look for information covering virtually all topics related to intraocular melanoma, from the essentials to the most advanced areas of research. The title of this book includes the word “official.” This reflects the fact that the sourcebook draws from public, academic, government, and peerreviewed research. Selected readings from various agencies are reproduced to give you some of the latest official information available to date on intraocular melanoma. Given patients’ increasing sophistication in using the Internet, abundant references to reliable Internet-based resources are provided throughout this sourcebook. Where possible, guidance is provided on how to obtain free-ofcharge, primary research results as well as more detailed information via the Internet. E-book and electronic versions of this sourcebook are fully interactive with each of the Internet sites mentioned (clicking on a hyperlink automatically opens your browser to the site indicated). Hard copy users of this sourcebook can type cited Web addresses directly into their browsers to obtain access to the corresponding sites. Since we are working with ICON Health Publications, hard copy Sourcebooks are frequently updated and printed on demand to ensure that the information provided is current. In addition to extensive references accessible via the Internet, every chapter presents a “Vocabulary Builder.” Many health guides offer glossaries of technical or uncommon terms in an appendix. In editing this sourcebook, we have decided to place a smaller glossary within each chapter that covers terms used in that chapter. Given the technical nature of some chapters, you may need to revisit many sections. Building one’s vocabulary of medical terms in such a gradual manner has been shown to improve the learning process. We must emphasize that no sourcebook on intraocular melanoma should affirm that a specific diagnostic procedure or treatment discussed in a research study, patent, or doctoral dissertation is “correct” or your best option. This sourcebook is no exception. Each patient is unique. Deciding on
Introduction
3
appropriate options is always up to the patient in consultation with their physician and healthcare providers.
Organization This sourcebook is organized into three parts. Part I explores basic techniques to researching intraocular melanoma (e.g. finding guidelines on diagnosis, treatments, and prognosis), followed by a number of topics, including information on how to get in touch with organizations, associations, or other patient networks dedicated to intraocular melanoma. It also gives you sources of information that can help you find a doctor in your local area specializing in treating intraocular melanoma. Collectively, the material presented in Part I is a complete primer on basic research topics for patients with intraocular melanoma. Part II moves on to advanced research dedicated to intraocular melanoma. Part II is intended for those willing to invest many hours of hard work and study. It is here that we direct you to the latest scientific and applied research on intraocular melanoma. When possible, contact names, links via the Internet, and summaries are provided. It is in Part II where the vocabulary process becomes important as authors publishing advanced research frequently use highly specialized language. In general, every attempt is made to recommend “free-to-use” options. Part III provides appendices of useful background reading for all patients with intraocular melanoma or related disorders. The appendices are dedicated to more pragmatic issues faced by many patients with intraocular melanoma. Accessing materials via medical libraries may be the only option for some readers, so a guide is provided for finding local medical libraries which are open to the public. Part III, therefore, focuses on advice that goes beyond the biological and scientific issues facing patients with intraocular melanoma.
Scope While this sourcebook covers intraocular melanoma, your doctor, research publications, and specialists may refer to your condition using a variety of terms. Therefore, you should understand that intraocular melanoma is often considered a synonym or a condition closely related to the following: ·
Eye Cancer
4
Intraocular Melanoma
·
Eye Tumor
·
Malignant Melanoma Choroid
·
Malignant Melanoma Eye
·
Ocular Melanoma
In addition to synonyms and related conditions, physicians may refer to intraocular melanoma using certain coding systems. The International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) is the most commonly used system of classification for the world’s illnesses. Your physician may use this coding system as an administrative or tracking tool. The following classification is commonly used for intraocular melanoma:4 ·
190 malignant neoplasm of eye
·
190.0 eyeball, except conjunctiva, cornea, retina, and choroid
·
190.1 orbit
·
190.2 lacrimal gland
·
190.3 conjunctiva
·
190.4 cornea
·
190.5 retina
·
190.6 choroid
·
190.7 lacrimal duct
·
190.8 other specified sites of eye
·
190.9 eye, part unspecified
·
224 benign neoplasm of eye
·
224.0 eyeball, except conjunctiva, cornea, retina, and choroid
·
224.1 orbit
·
224.2 lacrimal gland
·
224.3 conjunctiva
·
224.4 cornea
·
224.5 retina
4 This list is based on the official version of the World Health Organization’s 9th Revision, International Classification of Diseases (ICD-9). According to the National Technical Information Service, “ICD-9CM extensions, interpretations, modifications, addenda, or errata other than those approved by the U.S. Public Health Service and the Health Care Financing Administration are not to be considered official and should not be utilized. Continuous maintenance of the ICD-9-CM is the responsibility of the federal government.”
Introduction
·
224.6 choroid
·
224.7 lacrimal duct
·
224.8 other specified parts of eye
·
224.9 eye, part unspecified
5
For the purposes of this sourcebook, we have attempted to be as inclusive as possible, looking for official information for all of the synonyms relevant to intraocular melanoma. You may find it useful to refer to synonyms when accessing databases or interacting with healthcare professionals and medical librarians.
Moving Forward Since the 1980s, the world has seen a proliferation of healthcare guides covering most illnesses. Some are written by patients or their family members. These generally take a layperson’s approach to understanding and coping with an illness or disorder. They can be uplifting, encouraging, and highly supportive. Other guides are authored by physicians or other healthcare providers who have a more clinical outlook. Each of these two styles of guide has its purpose and can be quite useful. As editors, we have chosen a third route. We have chosen to expose you to as many sources of official and peer-reviewed information as practical, for the purpose of educating you about basic and advanced knowledge as recognized by medical science today. You can think of this sourcebook as your personal Internet age reference librarian. Why “Internet age”? All too often, patients diagnosed with intraocular melanoma will log on to the Internet, type words into a search engine, and receive several Web site listings which are mostly irrelevant or redundant. These patients are left to wonder where the relevant information is, and how to obtain it. Since only the smallest fraction of information dealing with intraocular melanoma is even indexed in search engines, a non-systematic approach often leads to frustration and disappointment. With this sourcebook, we hope to direct you to the information you need that you would not likely find using popular Web directories. Beyond Web listings, in many cases we will reproduce brief summaries or abstracts of available reference materials. These abstracts often contain distilled information on topics of discussion.
6
Intraocular Melanoma
While we focus on the more scientific aspects of intraocular melanoma, there is, of course, the emotional side to consider. Later in the sourcebook, we provide a chapter dedicated to helping you find peer groups and associations that can provide additional support beyond research produced by medical science. We hope that the choices we have made give you the most options available in moving forward. In this way, we wish you the best in your efforts to incorporate this educational approach into your treatment plan. The Editors
7
PART I: THE ESSENTIALS
ABOUT PART I Part I has been edited to give you access to what we feel are “the essentials” on intraocular melanoma. The essentials of a disease typically include the definition or description of the disease, a discussion of who it affects, the signs or symptoms associated with the disease, tests or diagnostic procedures that might be specific to the disease, and treatments for the disease. Your doctor or healthcare provider may have already explained the essentials of intraocular melanoma to you or even given you a pamphlet or brochure describing intraocular melanoma. Now you are searching for more in-depth information. As editors, we have decided, nevertheless, to include a discussion on where to find essential information that can complement what your doctor has already told you. In this section we recommend a process, not a particular Web site or reference book. The process ensures that, as you search the Web, you gain background information in such a way as to maximize your understanding.
Guidelines
CHAPTER 1. THE ESSENTIALS MELANOMA: GUIDELINES
ON
9
INTRAOCULAR
Overview Official agencies, as well as federally funded institutions supported by national grants, frequently publish a variety of guidelines on intraocular melanoma. These are typically called “Fact Sheets” or “Guidelines.” They can take the form of a brochure, information kit, pamphlet, or flyer. Often they are only a few pages in length. The great advantage of guidelines over other sources is that they are often written with the patient in mind. Since new guidelines on intraocular melanoma can appear at any moment and be published by a number of sources, the best approach to finding guidelines is to systematically scan the Internet-based services that post them.
The National Institutes of Health (NIH)5 The National Institutes of Health (NIH) is the first place to search for relatively current patient guidelines and fact sheets on intraocular melanoma. Originally founded in 1887, the NIH is one of the world’s foremost medical research centers and the federal focal point for medical research in the United States. At any given time, the NIH supports some 35,000 research grants at universities, medical schools, and other research and training institutions, both nationally and internationally. The rosters of those who have conducted research or who have received NIH support over the years include the world’s most illustrious scientists and physicians. Among them are 97 scientists who have won the Nobel Prize for achievement in medicine. 5
Adapted from the NIH: http://www.nih.gov/about/NIHoverview.html.
10 Intraocular Melanoma
There is no guarantee that any one Institute will have a guideline on a specific disease, though the National Institutes of Health collectively publish over 600 guidelines for both common and rare diseases. The best way to access NIH guidelines is via the Internet. Although the NIH is organized into many different Institutes and Offices, the following is a list of key Web sites where you are most likely to find NIH clinical guidelines and publications dealing with intraocular melanoma and associated conditions: ·
Office of the Director (OD); guidelines consolidated across agencies available at http://www.nih.gov/health/consumer/conkey.htm
·
National Library of Medicine (NLM); extensive encyclopedia (A.D.A.M., Inc.) with guidelines available at http://www.nlm.nih.gov/medlineplus/healthtopics.html
·
National Cancer Institute (NCI); guidelines available at http://cancernet.nci.nih.gov/pdq/pdq_treatment.shtml
Among the above, the National Cancer Institute (NCI) is particularly noteworthy. The NCI coordinates the National Cancer Program, which conducts and supports research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients.6 Specifically, the Institute: ·
Supports and coordinates research projects conducted by universities, hospitals, research foundations, and businesses throughout this country and abroad through research grants and cooperative agreements.
·
Conducts research in its own laboratories and clinics.
·
Supports education and training in fundamental sciences and clinical disciplines for participation in basic and clinical research programs and treatment programs relating to cancer through career awards, training grants, and fellowships.
·
Supports research projects in cancer control.
·
Supports a national network of cancer centers.
·
Collaborates with voluntary organizations and other national and foreign institutions engaged in cancer research and training activities.
·
Encourages and coordinates cancer research by industrial concerns where such concerns evidence a particular capability for programmatic research.
·
Collects and disseminates information on cancer.
This paragraph has been adapted from the NCI: http://www.nci.nih.gov/. “Adapted” signifies that a passage has been reproduced exactly or slightly edited for this book. 6
Guidelines 11
·
Supports construction of laboratories, clinics, and related facilities necessary for cancer research through the award of construction grants.
The NCI, established under the National Cancer Act of 1937, is the Federal Government’s principal agency for cancer research and training. The National Cancer Act of 1971 broadened the scope and responsibilities of the NCI and created the National Cancer Program. Over the years, legislative amendments have maintained the NCI authorities and responsibilities and added new information dissemination mandates as well as a requirement to assess the incorporation of state-of-the-art cancer treatments into clinical practice. Information dissemination is made possible through the NCI Online at www.cancer.gov. Cancer.gov offers to the public and physicians up-to-date information on the latest cancer research, current and upcoming clinical trials, statistics, research programs, and research funding. The following patient guideline was recently published by the NCI on intraocular melanoma.
What Is Intraocular Melanoma?7 Intraocular melanoma, a rare cancer, is a disease in which cancer (malignant) cells are found in the part of the eye called the uvea. The uvea contains cells called melanocytes, which contain color. When these cells become cancerous, the cancer is called a melanoma. The uvea includes the iris (the colored part of the eye), the ciliary body (a muscle in the eye), and the choroid (a layer of tissue in the back of the eye). The iris opens and closes to change the amount of light entering the eye. The ciliary body changes the shape of the lens inside the eye so it can focus. The choroid layer is next to the retina, the part of the eye that makes a picture. If there is melanoma that starts in the iris, it may look like a dark spot on the iris. If melanoma is in the ciliary body or the choroid, a person may have blurry vision or may have no symptoms, and the cancer may grow before it is noticed. Intraocular melanoma is usually found during a routine eye examination, when a doctor looks inside the eye with special lights and instruments. The chance of recovery (prognosis) depends on the size and cell type of the cancer, where the cancer is in the eye, and whether the cancer has spread. The following guidelines appeared on the NCI website on Aug. 26, 2002. The text was last modified in August 2002. The text has been adapted for this sourcebook. 7
12 Intraocular Melanoma
Stages of Intraocular Melanoma Once intraocular melanoma is found (diagnosed), more tests will be done to find out exactly what kind of tumor the patient has and whether cancer cells have spread to other parts of the body. This is called staging. A doctor needs to know the stage to plan treatment. Intraocular melanoma is staged based on the area of the eye where the tumor is found and the size of the tumor. Iris Intraocular melanomas of the iris occur in the front colored part of the eye. Iris melanomas usually grow slowly and do not usually spread to other parts of the body.
Ciliary Body/Choroid, Small Size Intraocular melanomas of the ciliary body and/or choroid occur in the back part of the eye. They are grouped by the size of the tumor. Small size ciliary body or choroid melanoma is 2 to 3 millimeters or less thick.
Ciliary Body/Choroid, Medium/Large Size Intraocular melanomas of the ciliary body and/or choroid occur in the back part of the eye. They are grouped by the size of the tumor. Medium/large size ciliary body or choroid melanoma is more than 2 to 3 millimeters thick.
Extraocular Extension The melanoma has spread outside the eye, to the nerve behind the eye (the optic nerve), or to the eye socket.
Guidelines 13
Recurrent Recurrent disease means that the cancer has come back (recurred) after it has been treated.
How Is Intraocular Melanoma Treated? There are treatments for all patients with intraocular melanoma. In some cases a doctor may watch the patient carefully without treatment until the cancer begins to grow. When treatment is given, three types of treatment are commonly used: ·
Surgery (taking out the cancer)
·
Radiation therapy (using high-dose x-rays or other high-energy rays to kill cancer cells)
·
Photocoagulation (destroying blood vessels that feed the tumor)
Surgery Surgery is the most common treatment of intraocular melanoma. A doctor may remove the cancer using one of the following operations: ·
Iridectomy removes only parts of the iris.
·
Iridotrabeculectomy removes parts of the iris and the supporting tissues around the cornea, the clear layer covering the front of the eye.
·
Iridocyclectomy removes parts of the iris and the ciliary body.
·
Choroidectomy removes parts of the choroid.
·
Enucleation removes the entire eye.
Radiation Therapy Radiation therapy uses x-rays or other high-energy rays to kill cancer cells and shrink tumors. Radiation may come from a machine outside the body (external beam radiation therapy) or from putting materials that contain radiation (radioisotopes) in the area where the cancer cells are found (internal radiation therapy). In intraocular melanoma, internal radiation may be put next to the eye using small implants called plaques. Radiation can be used alone or in combination with surgery.
14 Intraocular Melanoma
Photocoagulation Photocoagulation is a treatment that uses a tiny beam of light, usually from a laser, to destroy blood vessels and kill the tumor.
Treatment by Stage The choice of treatment depends on where the cancer is in the eye, how far it has spread, and the patient’s general health and age. Standard treatment may be considered because of its effectiveness in patients in past studies, or participation in a clinical trial may be considered. Not all patients are cured with standard therapy and some standard treatments may have more side effects than are desired. For these reasons, clinical trials are designed to find the best ways to treat cancer patients and are based on the most up-to-date information. A large clinical trial is ongoing in many parts of the country for patients with intraocular melanoma. To learn more about clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800422-6237); TTY at 1-800-332-8615.
Iris Melanoma If the tumor is small, there are no symptoms, and the tumor is not growing, treatment may not be needed. If the tumor begins to grow or if there are symptoms, treatment may be one of the following: ·
Surgery to remove parts of the iris (iridectomy).
·
Surgery to remove parts of the iris and the supporting tissues around the cornea (iridotrabeculectomy).
·
Surgery to remove parts of the iris and the ciliary body
·
Surgery to remove the eye (enucleation).
Ciliary Body and Choroid Melanoma, Small Size If the tumor is small, there are no symptoms, and the tumor is not growing, treatment may not be needed. If the tumor begins to grow, or if there are symptoms, treatment may be one of the following: ·
Internal radiation therapy.
Guidelines 15
·
External beam radiation therapy.
·
Surgery to remove the tumor and part of the iris or choroid (iridocyclectomy or choroidectomy).
·
Surgery to remove the eye (enucleation).
·
External beam radiation therapy followed by enucleation.
Ciliary Body and Choroid Melanoma, Medium/Large Size If the tumor is not growing, treatment may not be needed. If treatment is needed, it may be one of the following: ·
Internal radiation therapy.
·
External beam radiation therapy.
·
Surgery to remove the tumor and part of the iris or choroid (iridocyclectomy or choroidectomy).
·
Surgery to remove the eye (enucleation).
·
External beam radiation therapy followed by enucleation.
·
A clinical trial. A large trial is in progress in many parts of the country comparing standard treatments. Clinical trials are also testing new treatments.
Extraocular Extension Melanoma Treatment may be one of the following: ·
Surgery to remove the eye and other tissues in the eye socket (orbital exenteration) with or without radiation therapy.
·
Surgery to remove the eye (enucleation) with or without radiation therapy.
Recurrent Intraocular Melanoma Treatment will depend on the treatment the patient received before, the patient’s age and health, where the cancer came back, and how far the cancer has spread. The patient may want to take part in a clinical trial.
16 Intraocular Melanoma
To Learn More Call For more information, U.S. residents may call the National Cancer Institute’s (NCI’s) Cancer Information Service toll-free at 1-800-4-CANCER (1-800-4226237), Monday through Friday from 9:00 a.m. to 4:30 p.m. Deaf and hard-ofhearing callers with TTY equipment may call 1-800-332-8615. The call is free and a trained Cancer Information Specialist is available to answer your questions.
Web Sites and Organizations The NCI’s Cancer.gov Web site (http://cancer.gov) provides online access to information on cancer, clinical trials, and other Web sites and organizations that offer support and resources for cancer patients and their families. There are also many other places where people can get materials and information about cancer treatment and services. Local hospitals may have information on local and regional agencies that offer information about finances, getting to and from treatment, receiving care at home, and dealing with problems associated with cancer treatment.
Publications The NCI has booklets and other materials for patients, health professionals, and the public. These publications discuss types of cancer, methods of cancer treatment, coping with cancer, and clinical trials. Some publications provide information on tests for cancer, cancer causes and prevention, cancer statistics, and NCI research activities. NCI materials on these and other topics may be ordered online or printed directly from the NCI Publications Locator (https://cissecure.nci.nih.gov/ncipubs). These materials can also be ordered by telephone from the Cancer Information Service toll-free at 1-8004-CANCER (1-800-422-6237), TTY at 1-800-332-8615.
LiveHelp The NCI’s LiveHelp service, a program available on several of the Institute’s Web sites, provides Internet users with the ability to chat online with an Information Specialist. The service is available from Monday - Friday 9:00
Guidelines 17
AM - 10:00 PM Eastern Time. Information Specialists can help Internet users find information on NCI Web sites and answer questions about cancer.
Write For more information from the NCI, please write to this address: National Cancer Institute Office of Communications 31 Center Drive, MSC 2580 Bethesda, MD 20892-2580
About PDQ PDQ Is a Comprehensive Cancer Database Available on Cancer.gov PDQ is the National Cancer Institute’s (NCI’s) comprehensive cancer information database. Most of the information contained in PDQ is available online at Cancer.gov (http://cancer.gov), the NCI’s Web site. PDQ is provided as a service of the NCI. The NCI is part of the National Institutes of Health, the federal government’s focal point for biomedical research.
PDQ Contains Cancer Information Summaries The PDQ database contains summaries of the latest published information on cancer prevention, detection, genetics, treatment, supportive care, and complementary and alternative medicine. Most summaries are available in two versions. The health professional versions provide detailed information written in technical language. The patient versions are written in easy-tounderstand, non-technical language. Both versions provide current and accurate cancer information. The PDQ cancer information summaries are developed by cancer experts and reviewed regularly. Editorial Boards made up of experts in oncology and related specialties are responsible for writing and maintaining the cancer information summaries. The summaries are reviewed regularly and changes are made as new information becomes available. The date on each summary (“Date Last Modified”) indicates the time of the most recent change.
18 Intraocular Melanoma
PDQ Contains Information on Clinical Trials Before starting treatment, patients may want to think about taking part in a clinical trial. A clinical trial is a study to answer a scientific question, such as whether one treatment is better than another. Trials are based on past studies and what has been learned in the laboratory. Each trial answers certain scientific questions in order to find new and better ways to help cancer patients. During treatment clinical trials, information is collected about new treatments, the risks involved, and how well they do or do not work. If a clinical trial shows that a new treatment is better than one currently being used, the new treatment may become “standard.” Listings of clinical trials are included in PDQ and are available online at Cancer.gov (http://cancer.gov/clinical_trials). Descriptions of the trials are available in health professional and patient versions. Many cancer doctors who take part in clinical trials are also listed in PDQ. For more information, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237); TTY at 1-800-332-8615.
More Guideline Sources The guideline above on intraocular melanoma is only one example of the kind of material that you can find online and free of charge. The remainder of this chapter will direct you to other sources which either publish or can help you find additional guidelines on topics related to intraocular melanoma. Many of the guidelines listed below address topics that may be of particular relevance to your specific situation or of special interest to only some patients with intraocular melanoma. Due to space limitations these sources are listed in a concise manner. Do not hesitate to consult the following sources by either using the Internet hyperlink provided, or, in cases where the contact information is provided, contacting the publisher or author directly.
Topic Pages: MEDLINEplus For patients wishing to go beyond guidelines published by specific Institutes of the NIH, the National Library of Medicine has created a vast and patientoriented healthcare information portal called MEDLINEplus. Within this Internet-based system are “health topic pages.” You can think of a health topic page as a guide to patient guides. To access this system, log on to http://www.nlm.nih.gov/medlineplus/healthtopics.html. From there you
Guidelines 19
can either search using the alphabetical index or browse by broad topic areas. Recently, MEDLINEplus listed the following as being relevant to intraocular melanoma: ·
Guides On Intraocular Melanoma Melanoma http://www.nlm.nih.gov/medlineplus/melanoma.html
·
Guides on Human Anatomy and Systems Cancers Topics http://www.nlm.nih.gov/medlineplus/cancers.html Skin, Hair and Nails Topics http://www.nlm.nih.gov/medlineplus/skinhairandnails.html Eyes and Vision Topics http://www.nlm.nih.gov/medlineplus/eyesandvision.html
·
Other Guides Eye Cancer http://www.nlm.nih.gov/medlineplus/eyecancer.html
Within the health topic page dedicated to intraocular melanoma, the following was recently recommended to patients: ·
General/Overviews Malignant Melanoma Source: American Academy of Dermatology http://www.aad.org/pamphlets/malmel.html Melanoma http://www.nlm.nih.gov/medlineplus/tutorials/melanomaloader.ht ml
·
Diagnosis/Symptoms ABCDs of Melanoma Detection Source: American Academy of Dermatology http://www.aad.org/SkinCancerNews/WhatIsSkinCancer/ABCDM el.html
20 Intraocular Melanoma
·
Treatment Intraocular (Eye) Melanoma (PDQ): Treatment Source: National Cancer Institute http://www.cancer.gov/cancer_information/doc_pdq.aspx?version= patient&viewid=49d0b28a-ea54-4cd3-b017-64e34a2145ae Melanoma (PDQ): Treatment Source: National Cancer Institute http://www.cancer.gov/cancer_information/doc_pdq.aspx?version= patient&viewid=7763f63a-fc70-4792-a33f-bf1855968725
·
Coping Coping With Melanoma Source: Skin Cancer Foundation http://www.skincancer.org/melanoma/coping.html
·
Specific Conditions/Aspects About Choroidal Melanoma Source: Johns Hopkins University http://www.jhu.edu/wctb/coms/booklet/book2.htm Atypical Nevus Source: American Academy of Dermatology http://www.aad.org/pamphlets/anevus.html What You Need to Know about Moles and Dysplastic Nevi Source: National Cancer Institute http://www.cancer.gov/cancer_information/doc_wyntk.aspx?viewi d=c3508072-3797-40c7-848b-7bbbe9ce16d4
·
From the National Institutes of Health What You Need to Know about Melanoma Source: National Cancer Institute http://www.cancer.gov/cancer_information/doc_wyntk.aspx?viewi d=8f3e1c39-1ba0-4a7e-9088-e03c592c5395
·
Latest News Age, Gender Affect Melanoma Chemo Success Source: 10/23/2002, Reuters Health http://www.nlm.nih.gov/medlineplus/news/fullstory_9999.html
Guidelines 21
New Approach to Replacing Immune Cells Shrinks Tumors in Patients with Melanoma Source: 09/19/2002, National Cancer Institute http://www.nih.gov/news/pr/sep2002/nci-19.htm Study Looks at Melanoma Deaths, Age Source: 10/08/2002, Associated Press http://www.nlm.nih.gov/medlineplus/news/fullstory_9773.html ·
Organizations American Academy of Dermatology http://www.aad.org/ American Cancer Society http://www.cancer.org/ National Cancer Institute http://www.cancer.gov/ Skin Cancer Foundation http://www.skincancer.org/
·
Pictures/Diagrams Skin Lesions Source: American Academy of Dermatology http://www.skincarephysicians.com/melanomanet/skin_lesions.ht m
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Prevention/Screening Melanoma Cancer Questionnaire Source: Harvard Center for Cancer Prevention http://www.yourcancerrisk.harvard.edu/hccpquiz.pl?func=d_start& cancer_list=Melanoma Self-Examination for Melanoma Source: American Academy of Dermatology http://www.skincarephysicians.com/melanomanet/self_exam.htm
·
Research Cancer Research: Killing Tumor Cells With Anthrax-based Immunotoxin Source: National Institute of Dental and Craniofacial Research http://www.nidcr.nih.gov/news/inside_scoop_cancer_rsch.asp
22 Intraocular Melanoma
Individuals' Risk of Melanoma Increases With Time Outdoors, Especially in High-Sunlight Areas Source: National Cancer Institute http://newscenter.cancer.gov/pressreleases/individualmelanoma.ht ml New Approach to Replacing Immune Cells Shrinks Tumors in Patients with Melanoma Source: National Cancer Institute http://www.nih.gov/news/pr/sep2002/nci-19.htm ·
Statistics SEER Cancer Statistics Review 1973-1999: Melanomas of Skin Source: img src='/medlineplus/images/linkpdf.gif' width='100' height='17' border=0 alt='Links to PDF File'> (National Cancer Institute http://seer.cancer.gov/csr/1973_1999/melanoma.pdf
If you do not find topics of interest when browsing health topic pages, then you can choose to use the advanced search utility of MEDLINEplus at http://www.nlm.nih.gov/medlineplus/advancedsearch.html. This utility is similar to the NIH Search Utility, with the exception that it only includes material linked within the MEDLINEplus system (mostly patient-oriented information). It also has the disadvantage of generating unstructured results. We recommend, therefore, that you use this method only if you have a very targeted search. The National Guideline Clearinghouse™ The National Guideline Clearinghouse™ offers hundreds of evidence-based clinical practice guidelines published in the United States and other countries. You can search their site located at http://www.guideline.gov by using the keyword “intraocular melanoma” or synonyms. The following was recently posted: ·
ACR Appropriateness Criteria™ for orbits, vision and visual loss. Source: American College of Radiology.; 1999; 9 pages http://www.guideline.gov/FRAMESETS/guideline_fs.asp?guideline=00 1676&sSearch_string=intraocular+melanoma
Guidelines 23
Healthfinder™ Healthfinder™ is an additional source sponsored by the U.S. Department of Health and Human Services which offers links to hundreds of other sites that contain healthcare information. This Web site is located at http://www.healthfinder.gov. Again, keyword searches can be used to find guidelines. The following was recently found in this database: ·
Intraocular (Eye) Melanoma (PDQ®): Treatment Summary: Treatment information for patients based on information in the PDQ summary for health professionals on the cancer type -intraocular melanoma. Source: National Cancer Institute, National Institutes of Health http://www.healthfinder.gov/scripts/recordpass.asp?RecordType=0&R ecordID=5068 The NIH Search Utility
After browsing the references listed at the beginning of this chapter, you may want to explore the NIH Search Utility. This allows you to search for documents on over 100 selected Web sites that comprise the NIH-WEBSPACE. Each of these servers is “crawled” and indexed on an ongoing basis. Your search will produce a list of various documents, all of which will relate in some way to intraocular melanoma. The drawbacks of this approach are that the information is not organized by theme and that the references are often a mix of information for professionals and patients. Nevertheless, a large number of the listed Web sites provide useful background information. We can only recommend this route, therefore, for relatively rare or specific disorders, or when using highly targeted searches. To use the NIH search utility, visit the following Web page: http://search.nih.gov/index.html.
24 Intraocular Melanoma
Additional Web Sources A number of Web sites that often link to government sites are available to the public. These can also point you in the direction of essential information. The following is a representative sample: ·
AOL: http://search.aol.com/cat.adp?id=168&layer=&from=subcats
·
drkoop.comÒ: http://www.drkoop.com/conditions/ency/index.html
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Family Village: http://www.familyvillage.wisc.edu/specific.htm
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Google: http://directory.google.com/Top/Health/Conditions_and_Diseases/
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Med Help International: http://www.medhelp.org/HealthTopics/A.html
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Open Directory Project: http://dmoz.org/Health/Conditions_and_Diseases/
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Yahoo.com: http://dir.yahoo.com/Health/Diseases_and_Conditions/
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WebMDÒHealth: http://my.webmd.com/health_topics
Vocabulary Builder The material in this chapter may have contained a number of unfamiliar words. The following Vocabulary Builder introduces you to terms used in this chapter that have not been covered in the previous chapter: American Cancer Society: A voluntary organization concerned with the prevention and treatment of cancer through education and research. [NIH] Anthrax: An infectious bacterial zoonotic disease usually acquired by ingestion of Bacillus anthracis or its spores from infected pastures by herbivores or indirectly from infected carcasses by carnivores. It is transmitted to humans usually by contact with infected animals or their discharges (agricultural a.) or with contaminated animal products (industrial a.). Anthrax is classified by primary routes of inoculation as : cutaneous, gastrointestinal, and inhalational. Called also charbon, milzbrand and splenic fever. [EU] Cell: The individual unit that makes up all of the tissues of the body. All living things are made up of one or more cells. [NIH] Choroid: The thin, highly vascular membrane covering most of the posterior of the eye between the retina and sclera. [NIH] Cornea: The transparent part of the eye that covers the iris and the pupil
Guidelines 25
and allows light to enter the inside. [NIH] Dermatology: A medical specialty concerned with the skin, its structure, functions, diseases, and treatment. [NIH] Intraocular: Within the eye. [EU] Iris: The most anterior portion of the uveal layer, separating the anterior chamber from the posterior. It consists of two layers - the stroma and the pigmented epithelium. Color of the iris depends on the amount of melanin in the stroma on reflection from the pigmented epithelium. [NIH] Malignant: Cancerous; a growth with a tendency to invade and destroy nearby tissue and spread to other parts of the body. [NIH] Melanocytes: Cells in the skin that produce and contain the pigment called melanin. [NIH] Melanoma: A form of skin cancer that arises in melanocytes, the cells that produce pigment. Melanoma usually begins in a mole. [NIH] Millimeter: A measure of length. A millimeter is approximately 26-times smaller than an inch. [NIH] Oncology: The study of cancer. [NIH] Orbital: Pertaining to the orbit (= the bony cavity that contains the eyeball). [EU]
Radioisotope: An unstable element that releases radiation as it breaks down. Radioisotopes can be used in imaging tests or as a treatment for cancer. [NIH] Radiology: The use of radiation (such as x-rays) or other imaging technologies (such as ultrasound and magnetic resonance imaging) to diagnose or treat disease. [NIH] Retina: The ten-layered nervous tissue membrane of the eye. It is continuous with the optic nerve and receives images of external objects and transmits visual impulses to the brain. Its outer surface is in contact with the choroid and the inner surface with the vitreous body. The outer-most layer is pigmented, whereas the inner nine layers are transparent. [NIH] Screening: Checking for disease when there are no symptoms. [NIH] Staging: Performing exams and tests to learn the extent of the cancer within the body, especially whether the disease has spread from the original site to other parts of the body. [NIH]
Seeking Guidance 27
CHAPTER 2. SEEKING GUIDANCE Overview Some patients are comforted by the knowledge that a number of organizations dedicate their resources to helping people with intraocular melanoma. These associations can become invaluable sources of information and advice. Many associations offer aftercare support, financial assistance, and other important services. Furthermore, healthcare research has shown that support groups often help people to better cope with their conditions.8 In addition to support groups, your physician can be a valuable source of guidance and support. Therefore, finding a physician that can work with your unique situation is a very important aspect of your care. In this chapter, we direct you to resources that can help you find patient organizations and medical specialists. We begin by describing how to find associations and peer groups that can help you better understand and cope with intraocular melanoma. The chapter ends with a discussion on how to find a doctor that is right for you.
Associations and Intraocular Melanoma As mentioned by the Agency for Healthcare Research and Quality, sometimes the emotional side of an illness can be as taxing as the physical side.9 You may have fears or feel overwhelmed by your situation. Everyone has different ways of dealing with disease or physical injury. Your attitude, your expectations, and how well you cope with your condition can all Churches, synagogues, and other houses of worship might also have groups that can offer you the social support you need. 9 This section has been adapted from http://www.ahcpr.gov/consumer/diaginf5.htm. 8
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influence your well-being. This is true for both minor conditions and serious illnesses. For example, a study on female breast cancer survivors revealed that women who participated in support groups lived longer and experienced better quality of life when compared with women who did not participate. In the support group, women learned coping skills and had the opportunity to share their feelings with other women in the same situation. There are a number of directories that list additional medical associations that you may find useful. While not all of these directories will provide different information, by consulting all of them, you will have nearly exhausted all sources for patient associations.
The National Cancer Institute (NCI) The National Cancer Institute (NCI) has complied a list of national organizations that offer services to people with cancer and their families. To view the list, see the NCI fact sheet online at the following Web address: http://cis.nci.nih.gov/fact/8_1.htm. The name of each organization is accompanied by its contact information and a brief explanation of its services.
The National Health Information Center (NHIC) The National Health Information Center (NHIC) offers a free referral service to help people find organizations that provide information about intraocular melanoma. For more information, see the NHIC’s Web site at http://www.health.gov/NHIC/ or contact an information specialist by calling 1-800-336-4797.
DIRLINE A comprehensive source of information on associations is the DIRLINE database maintained by the National Library of Medicine. The database comprises some 10,000 records of organizations, research centers, and government institutes and associations which primarily focus on health and biomedicine. DIRLINE is available via the Internet at the following Web site: http://dirline.nlm.nih.gov/. Simply type in “intraocular melanoma” (or a synonym) or the name of a topic, and the site will list information contained in the database on all relevant organizations.
Seeking Guidance 29
The Combined Health Information Database Another comprehensive source of information on healthcare associations is the Combined Health Information Database. Using the “Detailed Search” option, you will need to limit your search to “Organizations” and “intraocular melanoma”. Type the following hyperlink into your Web browser: http://chid.nih.gov/detail/detail.html. To find associations, use the drop boxes at the bottom of the search page where “You may refine your search by.” For publication date, select “All Years.” Then, select your preferred language and the format option “Organization Resource Sheet.” By making these selections and typing in “intraocular melanoma” (or synonyms) into the “For these words:” box, you will only receive results on organizations dealing with intraocular melanoma. You should check back periodically with this database since it is updated every 3 months. The National Organization for Rare Disorders, Inc. The National Organization for Rare Disorders, Inc. has prepared a Web site that provides, at no charge, lists of associations organized by specific diseases. You can access this database at the following Web site: http://www.rarediseases.org/cgi-bin/nord/searchpage. Select the option called “Organizational Database (ODB)” and type “intraocular melanoma” (or a synonym) in the search box.
Cancer Support Groups10 People diagnosed with cancer and their families face many challenges that may leave them feeling overwhelmed, afraid, and alone. It can be difficult to cope with these challenges or to talk to even the most supportive family members and friends. Often, support groups can help people affected by cancer feel less alone and can improve their ability to deal with the uncertainties and challenges that cancer brings. Support groups give people who are affected by similar diseases an opportunity to meet and discuss ways to cope with the illness.
10
This section has been adapted from the NCI: http://cis.nci.nih.gov/fact/8_8.htm.
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How Can Support Groups Help? People who have been diagnosed with cancer sometimes find they need assistance coping with the emotional as well as the practical aspects of their disease. In fact, attention to the emotional burden of cancer is sometimes part of a patient’s treatment plan. Cancer support groups are designed to provide a confidential atmosphere where cancer patients or cancer survivors can discuss the challenges that accompany the illness with others who may have experienced the same challenges. For example, people gather to discuss the emotional needs created by cancer, to exchange information about their disease—including practical problems such as managing side effects or returning to work after treatment—and to share their feelings. Support groups have helped thousands of people cope with these and similar situations. Can Family Members and Friends Participate in Support Groups? Family and friends are affected when cancer touches someone they love, and they may need help in dealing with stresses such as family disruptions, financial worries, and changing roles within relationships. To help meet these needs, some support groups are designed just for family members of people diagnosed with cancer; other groups encourage families and friends to participate along with the cancer patient or cancer survivor. How Can People Find Support Groups? Many organizations offer support groups for people diagnosed with cancer and their family members or friends. The NCI fact sheet National Organizations That Offer Services to People with Cancer and Their Families lists many cancer-concerned organizations that can provide information about support groups. This fact sheet is available at http://cis.nci.nih.gov/fact/8_1.htm on the Internet, or can be ordered from the Cancer Information Service at 1–800–4–CANCER (1–800–422–6237). Some of these organizations provide information on their Web sites about contacting support groups. Doctors, nurses, or hospital social workers who work with cancer patients may also have information about support groups, such as their location, size, type, and how often they meet. Most hospitals have social services departments that provide information about cancer support programs.
Seeking Guidance 31
Additionally, many newspapers carry a special health supplement containing information about where to find support groups.
What Types of Support Groups Are Available? Several kinds of support groups are available to meet the individual needs of people at all stages of cancer treatment, from diagnosis through follow-up care. Some groups are general cancer support groups, while more specialized groups may be for teens or young adults, for family members, or for people affected by a particular disease. Support groups may be led by a professional, such as a psychiatrist, psychologist, or social worker, or by cancer patients or survivors. In addition, support groups can vary in approach, size, and how often they meet. Many groups are free, but some require a fee (people can contact their health insurance company to find out whether their plan will cover the cost). It is important for people to find an atmosphere that is comfortable and meets their individual needs. Online Support Groups In addition to support groups, commercial Internet service providers offer forums and chat rooms for people with different illnesses and conditions. WebMDÒ, for example, offers such a service at their Web site: http://boards.webmd.com/roundtable. These online self-help communities can help you connect with a network of people whose concerns are similar to yours. Online support groups are places where people can talk informally. If you read about a novel approach, consult with your doctor or other healthcare providers, as the treatments or discoveries you hear about may not be scientifically proven to be safe and effective.
The Cancer Information Service11 The Cancer Information Service (CIS) is a program of the National Cancer Institute (NCI), the Nation’s lead agency for cancer research. As a resource for information and education about cancer, the CIS is a leader in helping people become active participants in their own health care by providing the latest information on cancer in understandable language. Through its network of regional offices, the CIS serves the United States, Puerto Rico, the U.S. Virgin Islands, and the Pacific Islands. 11
This section has been adapted from the NCI: http://cis.nci.nih.gov/fact/2_5.htm.
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For 25 years, the Cancer Information Service has provided the latest and most accurate cancer information to patients and families, the public, and health professionals by: ·
Interacting with people one-on-one through its Information Service,
·
Working with organizations through its Partnership Program,
·
Participating in research efforts to find the best ways to help people adopt healthier behaviors,
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Providing access to NCI information over the Internet. How Does the CIS Assist the Public?
Through the CIS toll-free telephone service (1–800–4–CANCER), callers speak with knowledgeable, caring staff who are experienced at explaining medical information in easy-to-understand terms. CIS information specialists answer calls in English and Spanish. They also provide cancer information to deaf and hard of hearing callers through the toll-free TTY number (1–800– 332–8615). CIS staff have access to comprehensive, accurate information from the NCI on a range of cancer topics, including the most recent advances in cancer treatment. They take as much time as each caller needs, provide thorough and personalized attention, and keep all calls confidential. The CIS also provides live, online assistance to users of NCI Web sites through LiveHelp, an instant messaging service that is available from 9:00 a.m. to 7:30 p.m. Eastern time, Monday through Friday. Through LiveHelp, information specialists provide answers to questions about cancer and help in navigating Cancer.gov, the NCI’s Web site. Through the telephone numbers or LiveHelp service, CIS users receive: ·
Answers to their questions about cancer, including ways to prevent cancer, symptoms and risks, diagnosis, current treatments, and research studies;
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Written materials from the NCI;
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Referrals to clinical trials and cancer-related services, such as treatment centers, mammography facilities, or other cancer organizations;
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Assistance in quitting smoking from information specialists trained in smoking cessation counseling.
Seeking Guidance 33
What Kind of Assistance Does the CIS Partnership Program Offer? Through its Partnership Program, the CIS collaborates with established national, state, and regional organizations to reach minority and medically underserved audiences with cancer information. Partnership Program staff provide assistance to organizations developing programs that focus on breast and cervical cancer, clinical trials, tobacco control, and cancer awareness for special populations. To reach those in need, the CIS: ·
Helps bring cancer information to people who do not traditionally seek health information or who may have difficulties doing so because of educational, financial, cultural, or language barriers;
·
Provides expertise to organizations to help strengthen their ability to inform people they serve about cancer; and
·
Links organizations with similar goals and helps them plan and evaluate programs, develop coalitions, conduct training on cancer-related topics, and use NCI resources. How Do CIS Research Efforts Assist the Public?
The CIS plays an important role in research by studying the most effective ways to communicate with people about healthy lifestyles; health risks; and options for preventing, diagnosing, and treating cancer. The ability to conduct health communications research is a unique aspect of the CIS. Results from these research studies can be applied to improving the way the CIS communicates about cancer and can help other programs communicate more effectively. How Do People Reach the Cancer Information Service? ·
To speak with a CIS information specialist call 1–800–4–CANCER (1–800– 422–6237), 9:00 a.m. to 4:30 p.m. local time, Monday through Friday. Deaf or hard of hearing callers with TTY equipment may call 1–800–332–8615.
·
To obtain online assistance visit the NCI’s Cancer Information Web site at http://cancer.gov/cancer_information and click on the LiveHelp link between 9:00 a.m. and 7:30 p.m. Eastern time, Monday through Friday.
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For information 24 hours a day, 7 days a week call 1–800–4–CANCER and select option 4 to hear recorded information at any time.
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Visit NCI’s Web site at http://cancer.gov on the Internet.
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Visit the CIS Web site at http://cancer.gov/cis on the Internet.
34 Intraocular Melanoma
Finding Cancer Resources in Your Community12 If you have cancer or are undergoing cancer treatment, there are places in your community to turn to for help. There are many local organizations throughout the country that offer a variety of practical and support services to people with cancer. However, people often don’t know about these services or are unable to find them. National cancer organizations can assist you in finding these resources, and there are a number of things you can do for yourself. Whether you are looking for a support group, counseling, advice, financial assistance, transportation to and from treatment, or information about cancer, most neighborhood organizations, local health care providers, or area hospitals are a good place to start. Often, the hardest part of looking for help is knowing the right questions to ask. What Kind of Help Can I Get? Until now, you probably never thought about the many issues and difficulties that arise with a diagnosis of cancer. There are support services to help you deal with almost any type of problem that might occur. The first step in finding the help you need is knowing what types of services are available. The following pages describe some of these services and how to find them. ·
Information on Cancer. Most national cancer organizations provide a range of information services, including materials on different types of cancer, treatments, and treatment-related issues.
·
Counseling. While some people are reluctant to seek counseling, studies show that having someone to talk to reduces stress and helps people both mentally and physically. Counseling can also provide emotional support to cancer patients and help them better understand their illness. Different types of counseling include individual, group, family, self-help (sometimes called peer counseling), bereavement, patient-to-patient, and sexuality.
·
Medical Treatment Decisions. Often, people with cancer need to make complicated medical decisions. Many organizations provide hospital and physician referrals for second opinions and information on clinical trials (research studies with people), which may expand treatment options.
12
Adapted from the NCI: http://cis.nci.nih.gov/fact/8_9.htm.
Seeking Guidance 35
·
Prevention and Early Detection. While cancer prevention may never be 100 percent effective, many things (such as quitting smoking and eating healthy foods) can greatly reduce a person’s risk for developing cancer. Prevention services usually focus on smoking cessation and nutrition. Early detection services, which are designed to detect cancer when a person has no symptoms of disease, can include referrals for screening mammograms, Pap tests, or prostate exams.
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Home Health Care. Home health care assists patients who no longer need to stay in a hospital or nursing home, but still require professional medical help. Skilled nursing care, physical therapy, social work services, and nutrition counseling are all available at home.
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Hospice Care. Hospice is care focused on the special needs of terminally ill cancer patients. Sometimes called palliative care, it centers around providing comfort, controlling physical symptoms, and giving emotional support to patients who can no longer benefit from curative treatment. Hospice programs provide services in various settings, including the patient’s home, hospice centers, hospitals, or skilled nursing facilities. Your doctor or social worker can provide a referral for these services.
·
Rehabilitation. Rehabilitation services help people adjust to the effects of cancer and its treatment. Physical rehabilitation focuses on recovery from the physical effects of surgery or the side effects associated with chemotherapy. Occupational or vocational therapy helps people readjust to everyday routines, get back to work, or find employment.
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Advocacy. Advocacy is a general term that refers to promoting or protecting the rights and interests of a certain group, such as cancer patients. Advocacy groups may offer services to assist with legal, ethical, medical, employment, legislative, or insurance issues, among others. For instance, if you feel your insurance company has not handled your claim fairly, you may want to advocate for a review of its decision.
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Financial. Having cancer can be a tremendous financial burden to cancer patients and their families. There are programs sponsored by the government and nonprofit organizations to help cancer patients with problems related to medical billing, insurance coverage, and reimbursement issues. There are also sources for financial assistance, and ways to get help collecting entitlements from Medicaid, Medicare, and the Social Security Administration.
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Housing/Lodging. Some organizations provide lodging for the family of a patient undergoing treatment, especially if it is a child who is ill and the parents are required to accompany the child to treatment.
36 Intraocular Melanoma
·
Children’s Services. A number of organizations provide services for children with cancer, including summer camps, make-a-wish programs, and help for parents seeking child care. How to Find These Services
Often, the services that people with cancer are looking for are right in their own neighborhood or city. The following is a list of places where you can begin your search for help. ·
The hospital, clinic, or medical center where you see your doctor, received your diagnosis, or where you undergo treatment should be able to give you information. Your doctor or nurse may be able to tell you about your specific medical condition, pain management, rehabilitation services, home nursing, or hospice care.
·
Most hospitals also have a social work, home care, or discharge planning department. This department may be able to help you find a support group, a nonprofit agency that helps people who have cancer, or the government agencies that oversee Social Security, Medicare, and Medicaid. While you are undergoing treatment, be sure to ask the hospital about transportation, practical assistance, or even temporary child care. Talk to a hospital financial counselor in the business office about developing a monthly payment plan if you need help with hospital expenses.
·
The public library is an excellent source of information, as are patient libraries at many cancer centers. A librarian can help you find books and articles through a literature search.
·
A local church, synagogue, YMCA or YWCA, or fraternal order may provide financial assistance, or may have volunteers who can help with transportation and home care. Catholic Charities, the United Way, or the American Red Cross may also operate local offices. Some of these organizations may provide home care, and the United Way’s information and referral service can refer you to an agency that provides financial help. To find the United Way serving your community, visit their online directory at http://www.unitedway.org on the Internet or look in the White Pages of your local telephone book.
·
Local or county government agencies may offer low-cost transportation (sometimes called para-transit) to individuals unable to use public transportation. Most states also have an Area Agency on Aging that offers low-cost services to people over 60. Your hospital or community social worker can direct you to government agencies for entitlements,
Seeking Guidance 37
including Social Security, state disability, Medicaid, income maintenance, and food stamps. (Keep in mind that most applications to entitlement programs take some time to process.) The Federal government also runs the Hill-Burton program (1–800–638–0742), which funds certain medical facilities and hospitals to provide cancer patients with free or low-cost care if they are in financial need. Getting the Most From a Service: What To Ask No matter what type of help you are looking for, the only way to find resources to fit your needs is to ask the right questions. When you are calling an organization for information, it is important to think about what questions you are going to ask before you call. Many people find it helpful to write out their questions in advance, and to take notes during the call. Another good tip is to ask the name of the person with whom you are speaking in case you have follow-up questions. Below are some of the questions you may want to consider if you are calling or visiting a new agency and want to learn about how they can help: ·
How do I apply [for this service]?
·
Are there eligibility requirements? What are they?
·
Is there an application process? How long will it take? What information will I need to complete the application process? Will I need anything else to get the service?
·
Do you have any other suggestions or ideas about where I can find help?
The most important thing to remember is that you will rarely receive help unless you ask for it. In fact, asking can be the hardest part of getting help. Don’t be afraid or ashamed to ask for assistance. Cancer is a very difficult disease, but there are people and services that can ease your burdens and help you focus on your treatment and recovery.
Finding Doctors Who Specialize in Cancer Care13 One of the most important aspects of your treatment will be the relationship between you and your doctor or specialist. All patients with intraocular melanoma must go through the process of selecting a physician. A common way to find a doctor who specializes in cancer care is to ask for a referral 13
Adapted from the NCI: http://cis.nci.nih.gov/fact/7_47.htm.
38 Intraocular Melanoma
from your primary care physician. Sometimes, you may know a specialist yourself, or through the experience of a family member, coworker, or friend. The following resources may also be able to provide you with names of doctors who specialize in treating specific diseases or conditions. However, these resources may not have information about the quality of care that the doctors provide. ·
Your local hospital or its patient referral service may be able to provide you with a list of specialists who practice at that hospital.
·
Your nearest National Cancer Institute (NCI)-designated cancer center can provide information about doctors who practice at that center. The NCI fact sheet The National Cancer Institute Cancer Centers Program describes and gives contact information, including Web sites, for NCIdesignated cancer treatment centers around the country. Many of the cancer centers’ Web sites have searchable directories of physicians who practice at each facility. The NCI’s fact sheet is available at http://cis.nci.nih.gov/fact/1_2.htm on the Internet, or by calling the Cancer Information Service (CIS) at 1–800–4–CANCER (1–800–422–6237).
·
The American Board of Medical Specialties (ABMS) publishes a list of board-certified physicians. The Official ABMS Directory of Board Certified Medical Specialists lists doctors’ names along with their specialty and their educational background. This resource is available in most public libraries. The ABMS also has a Web site that can be used to verify whether a specific physician is board-certified. This free service is located at http://www.abms.org/newsearch.asp on the Internet. Verification of a physician’s board certification can also be obtained by calling the ABMS at 1–866–275–2267 (1–866–ASK–ABMS).
·
The American Medical Association (AMA) provides an online service called AMA Physician Select that offers basic professional information on virtually every licensed physician in the United States and its possessions. The database can be searched by doctor’s name or by medical specialty. The AMA Physician Select service is located at http://www.ama-assn.org/aps/amahg.htm on the Internet.
·
The American Society of Clinical Oncologists (ASCO) provides an online list of doctors who are members of ASCO. The member database has the names and affiliations of over 15,000 oncologists worldwide. It can be searched by doctor’s name, institution’s name, location, and/or type of board certification. This service is located at http://www.asco.org/people/db/html/m_db.htm on the Internet.
Seeking Guidance 39
·
The American College of Surgeons (ACOS) Fellowship Database is an online list of surgeons who are Fellows of the ACOS. The list can be searched by doctor’s name, geographic location, or medical specialty. This service is located at http://web.facs.org/acsdir/default.htm on the Internet. The ACOS can be contacted at 633 North Saint Clair Street, Chicago, IL 60611–3211; or by telephone at 312–202–5000.
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Local medical societies may maintain lists of doctors in each specialty.
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Public and medical libraries may have print directories of doctors’ names, listed geographically by specialty.
·
Your local Yellow Pages may have doctors listed by specialty under “Physicians.”
The Agency for Healthcare Research and Quality (AHRQ) offers Your Guide to Choosing Quality Health Care, which has information for consumers on choosing a health plan, a doctor, a hospital, or a long-term care provider. The Guide includes suggestions and checklists that you can use to determine which doctor or hospital is best for you. This resource is available at http://www.ahrq.gov/consumer/qntool.htm on the Internet. You can also order the Guide by calling the AHRQ Publications Clearinghouse at 1–800– 358–9295. If you are a member of a health insurance plan, your choice may be limited to doctors who participate in your plan. Your insurance company can provide you with a list of participating primary care doctors and specialists. It is important to ask your insurance company if the doctor you choose is accepting new patients through your health plan. You also have the option of seeing a doctor outside your health plan and paying the costs yourself. If you have a choice of health insurance plans, you may first wish to consider which doctor or doctors you would like to use, then choose a plan that includes your chosen physician(s). The National Comprehensive Cancer Network (NCCN) Physician Directory lists specialists who practice in the NCCN’s 19 member institutions across the U.S. To access the directory, go to http://www.nccn.org/ and click on “Physician Directory“. To use this service, you will be required to scroll to the bottom of the page and select “I agree.” Enter your search criteria and select “Find” at the bottom of the page. To obtain more information on a physician or institution, contact the institution’s Physician Referral Department or the NCCN Patient Information and Referral Service at 1-888909-NCCN or
[email protected].
40 Intraocular Melanoma
If the previous sources did not meet your needs, you may want to log on to the Web site of the National Organization for Rare Disorders (NORD) at http://www.rarediseases.org/. NORD maintains a database of doctors with expertise in various rare diseases. The Metabolic Information Network (MIN), 800-945-2188, also maintains a database of physicians with expertise in various metabolic diseases.
Selecting Your Doctor14 There are many factors to consider when choosing a doctor. To make the most informed decision, you may wish to speak with several doctors before choosing one. When you meet with each doctor, you might want to consider the following: ·
Does the doctor have the education and training to meet my needs?
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Does the doctor use the hospital that I have chosen?
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Does the doctor listen to me and treat me with respect?
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Does the doctor explain things clearly and encourage me to ask questions?
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What are the doctor’s office hours?
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Who covers for the doctor when he or she is unavailable? Will that person have access to my medical records?
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How long does it take to get an appointment with the doctor?
If you are choosing a surgeon, you may wish to ask additional questions about the surgeon’s background and experience with specific procedures. These questions may include: ·
Is the surgeon board-certified?15
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Has the surgeon been evaluated by a national professional association of surgeons, such as the American College of Surgeons (ACOS)?
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At which treatment facility or facilities does the surgeon practice?
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How often does the surgeon perform the type of surgery I need?
14 This
section has been adapted from the AHRQ: http://www.ahrq.gov/consumer/qntascii/qntdr.htm 15 While board certification is a good measure of a doctor’s knowledge, it is possible to receive quality care from doctors who are not board certified.
Seeking Guidance 41
·
How many of these procedures has the surgeon performed? What was the success rate?
It is important for you to feel comfortable with the specialist that you choose, because you will be working closely with that person to make decisions about your cancer treatment. Trust your own observations and feelings when deciding on a doctor for your medical care. Other health professionals and support services may also be important during cancer treatment. The National Cancer Institute fact sheet Your Health Care Team: Your Doctor Is Only the Beginning has information about these providers and services, and how to locate them. This fact sheet is located at http://cis.nci.nih.gov/fact/8_10.htm on the Internet, or can be obtained by calling the CIS at 1–800–4–CANCER (1–800–422–6237).
Working with Your Doctor16 Research has shown that patients who have good relationships with their doctors tend to be more satisfied with their care and have better results. Here are some tips to help you and your doctor become partners: ·
You know important things about your symptoms and your health history. Tell your doctor what you think he or she needs to know.
·
It is important to tell your doctor personal information, even if it makes you feel embarrassed or uncomfortable.
·
Bring a “health history” list with you (and keep it up to date).
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Always bring any medications you are currently taking with you to the appointment, or you can bring a list of your medications including dosage and frequency information. Talk about any allergies or reactions you have had to your medications.
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Tell your doctor about any natural or alternative medicines you are taking.
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Bring other medical information, such as x-ray films, test results, and medical records.
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Ask questions. If you don’t, your doctor will assume that you understood everything that was said.
This section has been adapted from the AHRQ: www.ahrq.gov/consumer/qntascii/qntdr.htm.
16
42 Intraocular Melanoma
·
Write down your questions before your visit. List the most important ones first to make sure that they are addressed.
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Consider bringing a friend with you to the appointment to help you ask questions. This person can also help you understand and/or remember the answers.
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Ask your doctor to draw pictures if you think that this would help you understand.
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Take notes. Some doctors do not mind if you bring a tape recorder to help you remember things, but always ask first.
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Let your doctor know if you need more time. If there is not time that day, perhaps you can speak to a nurse or physician assistant on staff or schedule a telephone appointment.
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Take information home. Ask for written instructions. Your doctor may also have brochures and audio and videotapes that can help you.
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After leaving the doctor’s office, take responsibility for your care. If you have questions, call. If your symptoms get worse or if you have problems with your medication, call. If you had tests and do not hear from your doctor, call for your test results. If your doctor recommended that you have certain tests, schedule an appointment to get them done. If your doctor said you should see an additional specialist, make an appointment.
By following these steps, you will enhance the relationship you will have with your physician.
Finding a Cancer Treatment Facility17 Choosing a treatment facility is another important consideration for getting the best medical care possible. Although you may not be able to choose which hospital treats you in an emergency, you can choose a facility for scheduled and ongoing care. If you have already found a doctor for your cancer treatment, you may need to choose a facility based on where your doctor practices. Your doctor may be able to recommend a facility that provides quality care to meet your needs. You may wish to ask the following questions when considering a treatment facility: ·
Has the facility had experience and success in treating my condition?
Adapted from the NCI: http://cis.nci.nih.gov/fact/7_47.htm. At this Web site, information on how to find treatment facilities is also available for patients living outside the U.S. 17
Seeking Guidance 43
·
Has the facility been rated by state, consumer, or other groups for its quality of care?
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How does the facility check and work to improve its quality of care?
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Has the facility been approved by a nationally recognized accrediting body, such as the American College of Surgeons (ACOS) and/or the Joint Commission on Accredited Healthcare Organizations (JCAHO)?
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Does the facility explain patients’ rights and responsibilities? Are copies of this information available to patients?
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Does the treatment facility offer support services, such as social workers and resources to help me find financial assistance if I need it?
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Is the facility conveniently located?
If you are a member of a health insurance plan, your choice of treatment facilities may be limited to those that participate in your plan. Your insurance company can provide you with a list of approved facilities. Although the costs of cancer treatment can be very high, you have the option of paying out-of-pocket if you want to use a treatment facility that is not covered by your insurance plan. If you are considering paying for treatment yourself, you may wish to discuss the potential costs with your doctor beforehand. You may also want to speak with the person who does the billing for the treatment facility. In some instances, nurses and social workers can provide you with more information about coverage, eligibility, and insurance issues. The following resources may help you find a hospital or treatment facility for your care: ·
The NCI fact sheet The National Cancer Institute Cancer Centers Program describes and gives contact information for NCI-designated cancer treatment centers around the country.
·
The ACOS accredits cancer programs at hospitals and other treatment facilities. More than 1,400 programs in the United States have been designated by the ACOS as Approved Cancer Programs. The ACOS Web site offers a searchable database of these programs at http://web.facs.org/cpm/default.htm on the Internet. The ACOS can be contacted at 633 North Saint Clair Street, Chicago, IL 60611–3211; or by telephone at 312–202–5000.
·
The JCAHO is an independent, not-for-profit organization that evaluates and accredits health care organizations and programs in the United States. It also offers information for the general public about choosing a
44 Intraocular Melanoma
treatment facility. The JCAHO Web site is located at http://www.jcaho.org on the Internet. The JCAHO is located at One Renaissance Boulevard, Oakbrook Terrace, IL 60181–4294. The telephone number is 630–792–5800. ·
The JCAHO offers an online Quality Check service that patients can use to determine whether a specific facility has been accredited by the JCAHO and view the organization’s performance reports. This service is located at http://www.jcaho.org/qualitycheck/directry/directry.asp on the Internet.
·
The AHRQ publication Your Guide To Choosing Quality Health Care has suggestions and checklists for choosing the treatment facility that is right for you.
Additional Cancer Support Information In addition to the references above, the NCI has set up guidance Web sites that offers information on issues relating to cancer. These include: ·
Facing Forward - A Guide for Cancer Survivors: http://www.cancer.gov/cancer_information/doc_img.aspx?viewid=cc93a 843-6fc0-409e-8798-5c65afc172fe
·
Taking Time: Support for People With Cancer and the People Who Care About Them: http://www.cancer.gov/cancer_information/doc_img.aspx?viewid=21a4 6445-a5c8-4fee-95a3-d9d0d665077a
·
When Cancer Recurs: Meeting the Challenge: http://www.cancer.gov/cancer_information/doc_img.aspx?viewid=9e13 d0d2-b7de-4bd6-87da-5750300a0dab
·
Your Health Care Team: Your Doctor Is Only the Beginning: http://cis.nci.nih.gov/fact/8_10.htm
Vocabulary Builder The following vocabulary builder provides definitions of words used in this chapter that have not been defined in previous chapters: Bereavement: Refers to the whole process of grieving and mourning and is associated with a deep sense of loss and sadness. [NIH] Cervical: Relating to the neck, or to the neck of any organ or structure.
Seeking Guidance 45
Cervical lymph nodes are located in the neck; cervical cancer refers to cancer of the uterine cervix, which is the lower, narrow end (the "neck") of the uterus. [NIH] Chemotherapy: Treatment with anticancer drugs. [NIH] Curative: Tending to overcome disease and promote recovery. [EU] Mammogram: An x-ray of the breast. [NIH] Mammography: The use of x-rays to create a picture of the breast. [NIH] Oncologist: A doctor who specializes in treating cancer. Some oncologists specialize in a particular type of cancer treatment. For example, a radiation oncologist specializes in treating cancer with radiation. [NIH] Palliative: 1. affording relief, but not cure. 2. an alleviating medicine. [EU] Pap test: The collection of cells from the cervix for examination under a microscope. It is used to detect changes that may be cancer or may lead to cancer, and can show noncancerous conditions, such as infection or inflammation. Also called a Pap smear. [NIH] Prostate: A gland in males that surrounds the neck of the bladder and the urethra. It secretes a substance that liquifies coagulated semen. It is situated in the pelvic cavity behind the lower part of the pubic symphysis, above the deep layer of the triangular ligament, and rests upon the rectum. [NIH]
Clinical Trials 47
CHAPTER 3. MELANOMA
CLINICAL TRIALS AND INTRAOCULAR
Overview Very few medical conditions have a single treatment. The basic treatment guidelines that your physician has discussed with you, or those that you have found using the techniques discussed in Chapter 1, may provide you with all that you will require. For some patients, current treatments can be enhanced with new or innovative techniques currently under investigation. In this chapter, we will describe how clinical trials work and show you how to keep informed of trials concerning intraocular melanoma.
What Is a Clinical Trial?18 Clinical trials involve the participation of people in medical research. Most medical research begins with studies in test tubes and on animals. Treatments that show promise in these early studies may then be tried with people. The only sure way to find out whether a new treatment is safe, effective, and better than other treatments for intraocular melanoma is to try it on patients in a clinical trial.
The discussion in this chapter has been adapted from the NIH and the NEI: www.nei.nih.gov/netrials/ctivr.htm.
18
48 Intraocular Melanoma
What Kinds of Clinical Trials Are There? Clinical trials are carried out in three phases: ·
Phase I. Researchers first conduct Phase I trials with small numbers of patients and healthy volunteers. If the new treatment is a medication, researchers also try to determine how much of it can be given safely.
·
Phase II. Researchers conduct Phase II trials in small numbers of patients to find out the effect of a new treatment on intraocular melanoma.
·
Phase III. Finally, researchers conduct Phase III trials to find out how new treatments for intraocular melanoma compare with standard treatments already being used. Phase III trials also help to determine if new treatments have any side effects. These trials--which may involve hundreds, perhaps thousands, of people--can also compare new treatments with no treatment. How Is a Clinical Trial Conducted?
Various organizations support clinical trials at medical centers, hospitals, universities, and doctors’ offices across the United States. The “principal investigator” is the researcher in charge of the study at each facility participating in the clinical trial. Most clinical trial researchers are medical doctors, academic researchers, and specialists. The “clinic coordinator” knows all about how the study works and makes all the arrangements for your visits. All doctors and researchers who take part in the study on intraocular melanoma carefully follow a detailed treatment plan called a protocol. This plan fully explains how the doctors will treat you in the study. The “protocol” ensures that all patients are treated in the same way, no matter where they receive care. Clinical trials are controlled. This means that researchers compare the effects of the new treatment with those of the standard treatment. In some cases, when no standard treatment exists, the new treatment is compared with no treatment. Patients who receive the new treatment are in the treatment group. Patients who receive a standard treatment or no treatment are in the “control” group. In some clinical trials, patients in the treatment group get a new medication while those in the control group get a placebo. A placebo is a harmless substance, a “dummy” pill, that has no effect on intraocular melanoma. In other clinical trials, where a new surgery or device (not a medicine) is being tested, patients in the control group may receive a “sham
Clinical Trials 49
treatment.” This treatment, like a placebo, has no effect on intraocular melanoma and does not harm patients. Researchers assign patients “randomly” to the treatment or control group. This is like flipping a coin to decide which patients are in each group. If you choose to participate in a clinical trial, you will not know which group you will be appointed to. The chance of any patient getting the new treatment is about 50 percent. You cannot request to receive the new treatment instead of the placebo or sham treatment. Often, you will not know until the study is over whether you have been in the treatment group or the control group. This is called a “masked” study. In some trials, neither doctors nor patients know who is getting which treatment. This is called a “double masked” study. These types of trials help to ensure that the perceptions of the patients or doctors will not affect the study results. Natural History Studies Unlike clinical trials in which patient volunteers may receive new treatments, natural history studies provide important information to researchers on how intraocular melanoma develops over time. A natural history study follows patient volunteers to see how factors such as age, sex, race, or family history might make some people more or less at risk for intraocular melanoma. A natural history study may also tell researchers if diet, lifestyle, or occupation affects how a disease or disorder develops and progresses. Results from these studies provide information that helps answer questions such as: How fast will a disease or disorder usually progress? How bad will the condition become? Will treatment be needed? What Is Expected of Patients in a Clinical Trial? Not everyone can take part in a clinical trial for a specific disease or disorder. Each study enrolls patients with certain features or eligibility criteria. These criteria may include the type and stage of disease or disorder, as well as, the age and previous treatment history of the patient. You or your doctor can contact the sponsoring organization to find out more about specific clinical trials and their eligibility criteria. If you are interested in joining a clinical trial, your doctor must contact one of the trial’s investigators and provide details about your diagnosis and medical history. If you participate in a clinical trial, you may be required to have a number of medical tests. You may also need to take medications and/or undergo
50 Intraocular Melanoma
surgery. Depending upon the treatment and the examination procedure, you may be required to receive inpatient hospital care. Or, you may have to return to the medical facility for follow-up examinations. These exams help find out how well the treatment is working. Follow-up studies can take months or years. However, the success of the clinical trial often depends on learning what happens to patients over a long period of time. Only patients who continue to return for follow-up examinations can provide this important long-term information.
Recent Trials on Intraocular Melanoma The National Institutes of Health and other organizations sponsor trials on various diseases and disorders. Because funding for research goes to the medical areas that show promising research opportunities, it is not possible for the NIH or others to sponsor clinical trials for every disease and disorder at all times. The following lists recent trials dedicated to intraocular melanoma.19 If the trial listed by the NIH is still recruiting, you may be eligible. If it is no longer recruiting or has been completed, then you can contact the sponsors to learn more about the study and, if published, the results. Further information on the trial is available at the Web site indicated. Please note that some trials may no longer be recruiting patients or are otherwise closed. Before contacting sponsors of a clinical trial, consult with your physician who can help you determine if you might benefit from participation. ·
17-N-Allylamino-17-Demethoxy Geldanamycin in Treating Patients With Advanced Epithelial Cancer, Malignant Lymphoma or Sarcoma Condition(s): leukemia; adult soft tissue sarcoma; bone cancer; ovarian sarcoma; lymphoma; eye cancer; uterine sarcoma Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); University of Pittsburgh Cancer Institute Purpose - Excerpt: Rationale: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Purpose: Phase I trial to study the effectiveness of 17-N-allylamino-17demethoxy geldanamycin in treating patients who have advanced epithelial cancer, malignant lymphoma or sarcoma. Phase(s): Phase I Study Type: Treatment
19
These are listed at www.ClinicalTrials.gov.
Clinical Trials 51
Contact(s): Pennsylvania; University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, 15213-3489, United States; Recruiting; Ramesh K. Ramanathan 412-648-6507. Study chairs or principal investigators: Ramesh K. Ramanathan, Study Chair; University of Pittsburgh Cancer Institute Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00004241;jsessionid=69E0D5 3DB35D2A831E1708E159344A14 ·
Amifostine to Protect From the Side Effects of Peripheral Stem Cell Transplantation in Treating Patients With High-Risk or Relapsed Solid Tumors Condition(s): childhood soft tissue sarcoma; childhood liver cancer; adult soft tissue sarcoma; bone cancer; ovarian sarcoma; testicular cancer; brain tumor; eye cancer; kidney tumor Study Status: This study is currently recruiting patients. Sponsor(s): University of Minnesota Cancer Center Purpose - Excerpt: Rationale: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of high-dose chemotherapy. Purpose: Phase I trial to study the effectiveness of amifostine in protecting from the side effects of peripheral stem cell transplantation in treating patients who have high-risk or relapsed solid tumors. Phase(s): Phase I Study Type: Supportive Care, Treatment Contact(s): Minnesota; University of Minnesota Cancer Center, Minneapolis, Minnesota, 55455, United States; Recruiting; John Peter Perentesis 612-626-2902. Study chairs or principal investigators: John Peter Perentesis, Study Chair; University of Minnesota Cancer Center Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00003926;jsessionid=69E0D5 3DB35D2A831E1708E159344A14
52 Intraocular Melanoma
·
Arsenic Trioxide in Treating Patients With Advanced Neuroblastoma or Other Childhood Solid Tumors Condition(s): childhood soft tissue sarcoma; childhood liver cancer; bone cancer; brain tumor; eye cancer; kidney tumor Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); Memorial Sloan-Kettering Cancer Center Purpose - Excerpt: Rationale: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Purpose: Phase II trial to study the effectiveness of arsenic trioxide in treating children who have advanced neuroblastoma or other solid tumors. Phase(s): Phase II Study Type: Treatment Contact(s): New York; Memorial Sloan-Kettering Cancer Center, New York, New York, 10021, United States; Recruiting; Brian H. Kushner 212639-6793. Study chairs or principal investigators: Brian H. Kushner, Study Chair; Memorial Sloan-Kettering Cancer Center Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00024258;jsessionid=69E0D5 3DB35D2A831E1708E159344A14
·
Azacitidine Plus Phenylbutyrate in Treating Patients With Advanced or Metastatic Solid Tumors That Have Not Responded to Previous Treatment Condition(s): leukemia; lymphoma; eye cancer Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); Sidney Kimmel Cancer Center Purpose - Excerpt: Rationale: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Purpose: Phase I trial to study the effectiveness of azacitidine plus phenylbutyrate in treating patients who have advanced or metastatic solid tumors that have not responded to previous treatment. Phase(s): Phase I Study Type: Treatment Contact(s): Maryland; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, 21231-2410, United States;
Clinical Trials 53
Recruiting; Michael A. Carducci 410-614-3977. Study chairs or principal investigators: Michael A. Carducci, Study Chair; Sidney Kimmel Cancer Center Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00005639;jsessionid=69E0D5 3DB35D2A831E1708E159344A14 ·
BMS-247550 in Treating Patients With Advanced Cancers Condition(s): leukemia; lymphoma; eye cancer Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); University of Texas Purpose - Excerpt: Rationale: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Purpose: Phase I trial to study the effectiveness of BMS-247550 in treating patients who have malignant solid tumors or lymphoma. Phase(s): Phase I Study Type: Treatment Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00006221;jsessionid=69E0D5 3DB35D2A831E1708E159344A14
·
Bryostatin 1 and Interleukin-2 in Treating Patients With Refractory Solid Tumors or Lymphoma Condition(s): leukemia; lymphoma; eye cancer Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); National Institute on Aging (NIA) Purpose - Excerpt: Rationale: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining chemotherapy and interleukin-2 may kill more cancer cells. Purpose: Phase I trial to study the effectiveness of bryostatin 1 and interleukin-2 in treating patients who have refractory solid tumors or lymphoma. Phase(s): Phase I Study Type: Treatment
54 Intraocular Melanoma
Contact(s): Louisiana; Louisiana State University Medical Center - New Orleans, New Orleans, Louisiana, 70112, United States; Recruiting; Igor Espinoza-Delgado 410-558-8190. Study chairs or principal investigators: Igor Espinoza-Delgado, Study Chair; National Institute on Aging (NIA) Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00003993;jsessionid=69E0D5 3DB35D2A831E1708E159344A14 ·
Busulfan in Treating Children and Adolescents With Refractory CNS Cancer Condition(s): leukemia; lymphoma; brain tumor; eye cancer Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); Pediatric Brain Tumor Consortium Purpose - Excerpt: Rationale: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Purpose: Phase I trial to study the effectiveness of intrathecal busulfan in treating children and adolescents who have refractory CNS cancer. Phase(s): Phase I Study Type: Treatment Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00006246;jsessionid=69E0D5 3DB35D2A831E1708E159344A14
·
Combination Chemotherapy and Bone Marrow Transplantation in Treating Patients With Aplastic Anemia or Hematologic Cancer Condition(s): leukemia; lymphoma; eye cancer Study Status: This study is currently recruiting patients. Sponsor(s): Roswell Park Cancer Institute Purpose - Excerpt: Rationale: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known which regimen of combination chemotherapy followed by bone marrow transplantation is most effective for aplastic anemia or hematologic cancer. Purpose: Phase II/III trial to determine the effectiveness of different regimens of combination
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chemotherapy followed by bone marrow transplantation in treating patients who have aplastic anemia or hematologic cancer. Phase(s): Phase II; Phase III Study Type: Treatment Contact(s): New York; Roswell Park Cancer Institute, Buffalo, New York, 14263-0001, United States; Recruiting; Philip L. McCarthy, Jr. 716-8458707. Study chairs or principal investigators: Philip L. McCarthy, Jr., Study Chair; Roswell Park Cancer Institute Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00003816;jsessionid=69E0D5 3DB35D2A831E1708E159344A14 ·
Combination Chemotherapy Followed by Bone Transplantation in Treating Patients With Rare Cancer
Marrow
Condition(s): testicular cancer; lymphoma; childhood soft tissue sarcoma; childhood liver cancer; eye cancer; head and neck cancer; kidney tumor; bone cancer Study Status: This study is currently recruiting patients. Sponsor(s): Memorial Sloan-Kettering Cancer Center Purpose - Excerpt: Rationale: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bone marrow transplantation may allow doctors to give higher doses of chemotherapy and kill more tumor cells. Purpose: Phase II trial to study the effectiveness of combination chemotherapy with thiotepa, carboplatin, and topotecan followed by bone marrow transplantation in treating patients who have metastatic or progressive rare cancer. Phase(s): Phase II Study Type: Treatment Contact(s): New York; Memorial Sloan-Kettering Cancer Center, New York, New York, 10021, United States; Recruiting; Brian H. Kushner 212639-6793. Study chairs or principal investigators: Brian H. Kushner, Study Chair; Memorial Sloan-Kettering Cancer Center Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00002515;jsessionid=69E0D5 3DB35D2A831E1708E159344A14
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Combination Chemotherapy Followed by Donor Bone Marrow Transplantation or Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer or Genetic Disorders Condition(s): leukemia; lymphoma; multiple myeloma; eye cancer Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Comprehensive Cancer Center
Institute
(NCI);
Herbert
Irving
Purpose - Excerpt: Rationale: Peripheral stem cell transplantation or bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. Purpose: Phase II trial to study the effectiveness of combination chemotherapy followed by donor bone marrow transplantation or peripheral stem cell transplantation in treating patients who have hematologic cancer or genetic disorders. Phase(s): Phase II Study Type: Treatment Contact(s): New York; Herbert Irving Comprehensive Cancer Center, New York, New York, 10032, United States; Recruiting; James H. Garvin, Jr. 212-305-9770. Study chairs or principal investigators: David G. Savage, Study Chair; Herbert Irving Comprehensive Cancer Center Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00008307;jsessionid=69E0D5 3DB35D2A831E1708E159344A14 ·
Flavopiridol in Treating Children With Relapsed or Refractory Solid Tumors or Lymphomas Condition(s): childhood soft tissue sarcoma; childhood liver cancer; bone cancer; lymphoma; brain tumor; eye cancer; kidney tumor Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); Children's Oncology Group Purpose - Excerpt: Rationale: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Purpose: Phase I trial to study the effectiveness of flavopiridol in treating children who have relapsed or refractory solid tumors or lymphoma. Phase(s): Phase I Study Type: Treatment Contact(s): see Web site below
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Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00012181;jsessionid=69E0D5 3DB35D2A831E1708E159344A14 ·
Genetic Testing Plus Irinotecan in Treating Patients With Solid Tumors or Lymphoma Condition(s): leukemia; lymphoma; eye cancer Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); University of Chicago Cancer Research Center Purpose - Excerpt: Rationale: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Genetic testing for a specific enzyme may help doctors determine whether side effects from or response to chemotherapy are related to a person's genetic makeup. Purpose: Phase I trial to study genetic testing and the effectiveness of irinotecan in treating patients who have solid tumors and lymphoma. Phase(s): Phase I Study Type: Treatment, Genetic Contact(s): Illinois; University of Chicago Cancer Research Center, Chicago, Illinois, 60637-1470, United States; Recruiting; Mark J. Ratain 773-702-4400. Study chairs or principal investigators: Mark J. Ratain, Study Chair; University of Chicago Cancer Research Center Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00003970;jsessionid=69E0D5 3DB35D2A831E1708E159344A14
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High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors Condition(s): testicular cancer; brain tumor; eye cancer Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); Memorial Sloan-Kettering Cancer Center Purpose - Excerpt: Rationale: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Purpose: Phase II trial to study the effectiveness of
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high-dose thiotepa plus peripheral stem cell transplantation in treating patients with refractory solid tumors. Phase(s): Phase II Study Type: Treatment Contact(s): New York; Memorial Sloan-Kettering Cancer Center, New York, New York, 10021, United States; Recruiting; Ira Dunkel 212-6392153; NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York, New York, 10016, United States; Recruiting; Sharon Gardner 212-263-8520. Study chairs or principal investigators: Ira Dunkel, Study Chair; Memorial Sloan-Kettering Cancer Center Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00003173;jsessionid=69E0D5 3DB35D2A831E1708E159344A14 ·
Levofloxacin to Prevent Infection Following Chemotherapy in Treating Patients With Solid Tumors or Lymphoma Condition(s): lung cancer; leukemia; testicular cancer; lymphoma; brain tumor; breast cancer; eye cancer Study Status: This study is currently recruiting patients. Sponsor(s): Cancer Research Campaign Clinical Trials Centre Purpose - Excerpt: Rationale: Giving antibiotics may be effective in preventing or controlling early infection in patients receiving chemotherapy for solid tumors or lymphoma. It is not yet known if levofloxacin if effective in preventing infection. Purpose: Randomized phase III trial to determine the effectiveness of levofloxacin in preventing infection in patients receiving chemotherapy for solid tumors or lymphoma. Phase(s): Phase III Study Type: Supportive Care Contact(s): United Kingdom, England; University of Birmingham, Birmingham, England, B15 2TT, United Kingdom; Recruiting; Steven M. Neil 0121-414-2803. Study chairs or principal investigators: Steven M. Neil, Study Chair; Cancer Research Campaign Clinical Trials Centre Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00005590;jsessionid=69E0D5 3DB35D2A831E1708E159344A14
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Liposomal Amphotericin B in Treating Granulocytopenia and Persistent Unexplained Fever in Cancer Patients Condition(s): leukemia; testicular cancer; ovarian epithelial cancer; lymphoma; breast cancer; multiple myeloma; eye cancer; kidney tumor Study Status: This study is currently recruiting patients. Sponsor(s): EORTC Invasive Fungal Infections Cooperative Group Purpose - Excerpt: Rationale: Liposomal amphotericin B may be effective in controlling fever and granulocytopenia. It is not yet known which regimen of liposomal amphotericin B is more effective in treating cancer patients who have these conditions. Purpose: Randomized phase III trial to compare the effectiveness of two regimens of liposomal amphotericin B in treating granulocytopenia and fever in cancer patients. Phase(s): Phase III Study Type: Supportive Care Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00003938;jsessionid=69E0D5 3DB35D2A831E1708E159344A14
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Monoclonal Antibody and Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Has Been Removed During Surgery Condition(s): ciliary body and choroid melanoma, medium/large size; stage IV melanoma; extraocular extension melanoma; recurrent intraocular melanoma; stage III melanoma; iris melanoma; recurrent melanoma; ciliary body and choroid melanoma, small size Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); University of Southern California Purpose - Excerpt: Rationale: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Vaccines made from a person's cancer cells may make the body build an immune response to kill tumor cells. Purpose: Phase I trial to study the effectiveness of combining monoclonal antibody therapy and vaccine therapy in treating patients who have stage III or stage IV melanoma that has been removed during surgery. Phase(s): Phase I Study Type: Treatment
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Contact(s): California; USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, 90033-0804, United States; Recruiting; Jeffrey S. Weber 323-865-0712. Study chairs or principal investigators: Jeffrey S. Weber, Study Chair; University of Southern California Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00025181;jsessionid=69E0D5 3DB35D2A831E1708E159344A14 ·
Monoclonal Antibody Leptomeningeal Cancer
Therapy
in
Treating
Patients
With
Condition(s): lung cancer; melanoma; childhood soft tissue sarcoma; brain tumor; eye cancer; bone cancer Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); Memorial Sloan-Kettering Cancer Center Purpose - Excerpt: Rationale: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Purpose: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have leptomeningeal cancer. Phase(s): Phase I Study Type: Treatment Contact(s): New York; Memorial Sloan-Kettering Cancer Center, New York, New York, 10021, United States; Recruiting; Nai-Kong V. Cheung 212-639-8401. Study chairs or principal investigators: Nai-Kong V. Cheung, Study Chair; Memorial Sloan-Kettering Cancer Center Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00003022;jsessionid=69E0D5 3DB35D2A831E1708E159344A14 ·
Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer Condition(s): leukemia; lymphoma; multiple myeloma; eye cancer Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Comprehensive Cancer Center
Institute
(NCI);
Herbert
Irving
Purpose - Excerpt: Rationale: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy used to kill tumor cells. Purpose: Phase II trial to study
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the effectiveness of donor peripheral stem cell transplantation in treating patients who have hematologic cancer. Phase(s): Phase II Study Type: Treatment Contact(s): New York; Herbert Irving Comprehensive Cancer Center, New York, New York, 10032, United States; Recruiting; James H. Garvin, Jr. 212-305-9770. Study chairs or principal investigators: David G. Savage, Study Chair; Herbert Irving Comprehensive Cancer Center Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00008216;jsessionid=69E0D5 3DB35D2A831E1708E159344A14 ·
Pyrazoloacridine in Treating Patients With Metastatic Skin or Eye Melanoma Condition(s): ciliary body and choroid melanoma, medium/large size; stage IV melanoma; extraocular extension melanoma; recurrent intraocular melanoma; iris melanoma; recurrent melanoma; ciliary body and choroid melanoma, small size Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); Sidney Kimmel Cancer Center Purpose - Excerpt: Rationale: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Purpose: Phase II trial to study the effectiveness of pyrazoloacridine in treating patients who have metastatic skin or eye melanoma. Phase(s): Phase II Study Type: Treatment Contact(s): Maryland; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, 21231-2410, United States; Recruiting; William Howard Sharfman 410-583-2970. Study chairs or principal investigators: William Howard Sharfman, Study Chair; Sidney Kimmel Cancer Center Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00003802;jsessionid=69E0D5 3DB35D2A831E1708E159344A14
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Rebeccamycin Analog and Cisplatin With or Without Filgrastim in Treating Patients With Advanced Cancer Condition(s): leukemia; lymphoma; eye cancer
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Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); University of Texas Purpose - Excerpt: Rationale: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Colonystimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. Purpose: Phase I trial to study the effectiveness of rebeccamycin analog and cisplatin with or without filgrastim in treating patients who have advanced cancer. Phase(s): Phase I Study Type: Treatment Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00004189;jsessionid=69E0D5 3DB35D2A831E1708E159344A14 ·
Rebeccamycin Analogue in Treating Children With Solid Tumors or Non-Hodgkin's Lymphoma Condition(s): bone cancer; lymphoma; brain tumor; eye cancer Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); Children's Oncology Group Purpose - Excerpt: Rationale: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Purpose: Phase II trial to study the effectiveness of rebeccamycin analogue in treating children who have solid tumors or non-Hodgkin's lymphoma. Phase(s): Phase II Study Type: Treatment Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00006102;jsessionid=69E0D5 3DB35D2A831E1708E159344A14
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STI571 in Treating Patients With Advanced Cancer and Liver Dysfunction Condition(s): leukemia; lymphoma; eye cancer
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Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); University of Pittsburgh Cancer Institute Purpose - Excerpt: Rationale: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Purpose: Phase I trial to study the effectiveness of STI571 in treating patients who have advanced cancer and liver dysfunction. Phase(s): Phase I Study Type: Treatment Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00025415;jsessionid=69E0D5 3DB35D2A831E1708E159344A14 ·
Temozolomide and Interferon alfa in Treating Patients With Stage III or Stage IV Melanoma Condition(s): stage IV melanoma; extraocular extension melanoma; recurrent intraocular melanoma; stage III melanoma; iris melanoma; recurrent melanoma Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); Memorial Sloan-Kettering Cancer Center Purpose - Excerpt: Rationale: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy with interferon alfa may kill more tumor cells. Purpose: Phase II trial to study the effectiveness of combining temozolomide and interferon alfa in treating patients who have stage III or stage IV melanoma. Phase(s): Phase II Study Type: Treatment Contact(s): New York; Memorial Sloan-Kettering Cancer Center, New York, New York, 10021, United States; Recruiting; Wen-Jen Hwu 212-6395096. Study chairs or principal investigators: Wen-Jen Hwu, Study Chair; Memorial Sloan-Kettering Cancer Center Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00027742;jsessionid=69E0D5 3DB35D2A831E1708E159344A14
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Temozolomide and Thalidomide in Treating Patients With Stage III or Stage IV Melanoma Condition(s): ciliary body and choroid melanoma, medium/large size; stage IV melanoma; extraocular extension melanoma; recurrent intraocular melanoma; stage III melanoma; iris melanoma; recurrent melanoma; ciliary body and choroid melanoma, small size Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); Memorial Sloan-Kettering Cancer Center Purpose - Excerpt: Rationale: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of melanoma by stopping blood flow to the tumor. Combining chemotherapy with thalidomide may kill more tumor cells. Purpose: Phase I/II trial to study the effectiveness temozolomide plus thalidomide in treating patients who have stage III or stage IV melanoma that cannot be removed during surgery. Phase(s): Phase I; Phase II Study Type: Treatment Contact(s): New York; Memorial Sloan-Kettering Cancer Center, New York, New York, 10021, United States; Recruiting; Paul B. Chapman 212639-5015. Study chairs or principal investigators: Wen-Jen Hwu, Study Chair; Memorial Sloan-Kettering Cancer Center Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00005815;jsessionid=69E0D5 3DB35D2A831E1708E159344A14
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Tissue Studies of Human Eye Diseases Condition(s): Conjunctival Disease; Corneal Disease; Eye Disease; Uveitis; Vitreoretinopathy, Proliferative Study Status: This study is currently recruiting patients. Sponsor(s): National Eye Institute (NEI) Purpose - Excerpt: The purpose of this study is to better understand the processes involved in the development of various eye conditions, such as uveitis, disorders of the conjunctiva, cornea, vitreous and retina, metabolic or genetic eye diseases or eye tumors, in order to develop better methods of diagnosis and treatment. Patients who require eye surgery to treat an eye disease or other disease in which the eye is involved may participate in this study. Samples of eye tissue and fluid
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that are normally removed and discarded during eye surgery will instead be given to researchers for study. The tissues will be examined under microscope and studied using sophisticated chemical and biological tests. Immune cells from blood samples may also be examined. These studies will help better understand and diagnose the various eye diseases and to develop more attractive therapies. Study Type: Observational Contact(s): Maryland; National Eye Institute (NEI), 9000 Rockville Pike Bethesda, Maryland, 20892, United States; Recruiting; Patient Recruitment and Public Liaison Office 1-800-411-1222
[email protected]; TTY 1-866-411-1010 Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00001310;jsessionid=69E0D5 3DB35D2A831E1708E159344A14 ·
Vaccine Therapy and Interleukin-12 With Either Alum Sargramostim After Surgery in Treating Patients With Melanoma
or
Condition(s): ciliary body and choroid melanoma, medium/large size; stage IV melanoma; extraocular extension melanoma; recurrent intraocular melanoma; stage II melanoma; stage III melanoma; iris melanoma; recurrent melanoma; ciliary body and choroid melanoma, small size Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); University of Southern California Purpose - Excerpt: Rationale: Vaccines made from peptides may make the body build an immune response. Combining vaccine therapy with interleukin-12 and either alum or sargramostim may kill more tumor cells. Purpose: Randomized phase II trial to compare the effectiveness of combining vaccine therapy with interleukin-12 and either alum or sargramostim in treating patients who have undergone surgery for stage II, stage III, or stage IV melanoma. Phase(s): Phase II Study Type: Treatment Contact(s): California; USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, 90033-0804, United States; Recruiting; Jeffrey S. Weber 323-865-0712. Study chairs or principal investigators: Jeffrey S. Weber, Study Chair; University of Southern California
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Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00031733;jsessionid=69E0D5 3DB35D2A831E1708E159344A14 ·
Vaccine Therapy and/or Sargramostim in Treating Patients With Locally or Advanced Metastatic Melanoma Condition(s): ciliary body and choroid melanoma, medium/large size; stage IV melanoma; extraocular extension melanoma; recurrent intraocular melanoma; stage III melanoma; iris melanoma; recurrent melanoma; recurrent carcinoma of unknown primary Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); Eastern Cooperative Oncology Group Purpose - Excerpt: Rationale: Vaccines may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow or peripheral blood. It is not yet known which treatment regimen is more effective for metastatic melanoma. Purpose: Randomized phase III trial to determine the effectiveness of peptide vaccine therapy and/or sargramostim in treating patients who have locally advanced or metastatic melanoma. Phase(s): Phase III Study Type: Treatment Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00005034;jsessionid=69E0D5 3DB35D2A831E1708E159344A14
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VNP40101M in Treating Patients With Advanced Solid Tumors or Lymphomas Condition(s): leukemia; lymphoma; eye cancer Study Status: This study is currently recruiting patients. Sponsor(s): Vion Pharmaceuticals Purpose - Excerpt: Rationale: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Purpose: Phase I trial to study the effectiveness of VNP40101M in treating patients who have advanced solid tumors or lymphomas. Phase(s): Phase I
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Study Type: Treatment Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00025129;jsessionid=69E0D5 3DB35D2A831E1708E159344A14 ·
XK469 in Treating Patients With Advanced Solid Tumors or Lymphoma Condition(s): leukemia; lymphoma; eye cancer Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); University of Chicago Cancer Research Center Purpose - Excerpt: Rationale: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Purpose: Phase I trial to study the effectiveness of XK469 in treating patients who have advanced solid tumors or lymphoma. Phase(s): Phase I Study Type: Treatment Contact(s): Illinois; University of Chicago Cancer Research Center, Chicago, Illinois, 60637-1470, United States; Recruiting; Mark J. Ratain 773-702-4400. Study chairs or principal investigators: Mark J. Ratain, Study Chair; University of Chicago Cancer Research Center Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00028522;jsessionid=69E0D5 3DB35D2A831E1708E159344A14
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Collaborative Ocular Melanoma Study (COMS) Condition(s): Choroid Neoplasms; Uveitis Study Status: This study is no longer recruiting patients. Sponsor(s): National Eye Institute (NEI) Purpose - Excerpt: To evaluate therapeutic interventions for patients who have choroidal melanoma, the most common primary eye cancer affecting adults, and to assess the potential life-preserving as well as sight-preserving role of radiation therapy. To determine which of two standard treatments, removal of the eye or brachytherapy, is more likely to prolong survival of eligible patients with medium-sized choroidal melanoma. To determine whether preoperative radiation prolongs life for patients whose eyes with large choroidal melanoma are enucleated.
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Phase(s): Phase III Study Type: Interventional Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00000124;jsessionid=69E0D5 3DB35D2A831E1708E159344A14 ·
gp100 and MART-1 Peptide Vaccine for Metastatic Ocular Melanoma Condition(s): Melanoma Study Status: This study is completed. Sponsor(s): National Cancer Institute (NCI) Purpose - Excerpt: This study will examine the effectiveness and side effects of an experimental vaccine to treat ocular metastatic melanoma. Melanoma tumors produce proteins called gp100 and MART-1. Vaccination with specific pieces of these proteins (peptides) may boost the immune system's fight against the cancer. The vaccine injections are mixed with an oil-based substance called Montanide ISA-51, which is intended to increase the immune response to the peptide. Patients 16 years of age and older with progressive metastatic ocular melanoma and for whom standard treatments no longer work may be eligible for this study. Candidates will be screened with a complete physical and examination, including an eye examination, blood and urine tests, chest X-ray, electrocardiogram, X-ray and nuclear medicine imaging scans to evaluate the size and extent of tumor, and, if needed, a cardiac stress test and lung function test. In addition, patients will be tested for their HLA tissue type; patients must be type HLA-A*0201, the type on which this vaccine is based. Participants will receive two injections of both peptide vaccines (a total of four shots) in the thigh each week for 4 weeks. Some patients may undergo a biopsy -surgical removal of a small piece of tissue under local anesthetic-of normal skin and tumor or lymph node tissue to examine the effects of the vaccines on the tumor immune cells. Patients will also undergo plasmapheresis-a procedure to collect white blood cells-before treatment begins, after the second vaccination and 3 weeks after the fourth vaccination. For this procedure, blood is drawn through a needle in the arm, similar to donating blood. The blood goes through a machine that separates out the white cells (immune system cells), and the rest of the blood is returned through a needle in the other arm. Patients return for follow-up 3 to 4 weeks after the fourth injection. Patients in whom disease has not progressed or whose tumor has shrunk may receive additional 4-week treatment courses for up to 6 courses (24 immunizations). Patients whose tumor has not responded to therapy and
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who are physically eligible to receive a substance called interleukin-2 (IL2) may receive a second series of vaccines together with this agent. IL-2 may boost the immune response to the peptides. It is given intravenously (through a small tube placed in a vein) every 8 hours for 5 days after each vaccination. Patients who respond to the vaccine and IL-2 may be offered additional courses of this treatment regimen. Phase(s): Phase II Study Type: Interventional Contact(s): Maryland; National Cancer Institute (NCI), 9000 Rockville Pike Bethesda, Maryland, 20892, United States Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00009516;jsessionid=69E0D5 3DB35D2A831E1708E159344A14 ·
Pyroxamide in Treating Patients With Advanced Cancer Condition(s): leukemia; lymphoma; multiple myeloma; eye cancer Study Status: This study is not yet open for patient recruitment. Sponsor(s): National Cancer Institute (NCI); Memorial Sloan-Kettering Cancer Center Purpose - Excerpt: Rationale: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Purpose: Phase I trial to study the effectiveness of pyroxamide in treating patients who have advanced cancer. Phase(s): Phase I Study Type: Treatment Contact(s): Leonard Bruce Saltz 212-639-2501. Study chairs or principal investigators: Leonard Bruce Saltz, Study Chair; Memorial SloanKettering Cancer Center Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00042900;jsessionid=69E0D5 3DB35D2A831E1708E159344A14
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Benefits and Risks20 What Are the Benefits of Participating in a Clinical Trial? If you are interested in a clinical trial, it is important to realize that your participation can bring many benefits to you and society at large: ·
A new treatment could be more effective than the current treatment for intraocular melanoma. Although only half of the participants in a clinical trial receive the experimental treatment, if the new treatment is proved to be more effective and safer than the current treatment, then those patients who did not receive the new treatment during the clinical trial may be among the first to benefit from it when the study is over.
·
If the treatment is effective, then it may improve health or prevent diseases or disorders.
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Clinical trial patients receive the highest quality of medical care. Experts watch them closely during the study and may continue to follow them after the study is over.
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People who take part in trials contribute to scientific discoveries that may help other people with intraocular melanoma. In cases where certain diseases or disorders run in families, your participation may lead to better care or prevention for your family members. The Informed Consent
Once you agree to take part in a clinical trial, you will be asked to sign an “informed consent.” This document explains a clinical trial’s risks and benefits, the researcher’s expectations of you, and your rights as a patient.
What Are the Risks? Clinical trials may involve risks as well as benefits. Whether or not a new treatment will work cannot be known ahead of time. There is always a chance that a new treatment may not work better than a standard treatment. There is also the possibility that it may be harmful. The treatment you receive may cause side effects that are serious enough to require medical attention. This section has been adapted from ClinicalTrials.gov, a service of the National Institutes of Health: http://www.clinicaltrials.gov/ct/gui/c/a1r/info/whatis?JServSessionIdzone_ct=9jmun6f291. 20
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How Is Patient Safety Protected? Clinical trials can raise fears of the unknown. Understanding the safeguards that protect patients can ease some of these fears. Before a clinical trial begins, researchers must get approval from their hospital’s Institutional Review Board (IRB), an advisory group that makes sure a clinical trial is designed to protect patient safety. During a clinical trial, doctors will closely watch you to see if the treatment is working and if you are experiencing any side effects. All the results are carefully recorded and reviewed. In many cases, experts from the Data and Safety Monitoring Committee carefully monitor each clinical trial and can recommend that a study be stopped at any time. You will only be asked to take part in a clinical trial as a volunteer giving informed consent. What Are a Patient’s Rights in a Clinical Trial? If you are eligible for a clinical trial, you will be given information to help you decide whether or not you want to participate. As a patient, you have the right to: ·
Information on all known risks and benefits of the treatments in the study.
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Know how the researchers plan to carry out the study, for how long, and where.
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Know what is expected of you.
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Know any costs involved for you or your insurance provider.
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Know before any of your medical or personal information is shared with other researchers involved in the clinical trial.
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Talk openly with doctors and ask any questions.
After you join a clinical trial, you have the right to: ·
Leave the study at any time. Participation is strictly voluntary. However, you should not enroll if you do not plan to complete the study.
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Receive any new information about the new treatment.
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Continue to ask questions and get answers.
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Maintain your privacy. Your name will not appear in any reports based on the study.
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Know whether you participated in the treatment group or the control group (once the study has been completed).
What Should You Ask before Deciding to Join a Clinical Trial? Questions you should ask when thinking about joining a clinical trial include the following: ·
What is the purpose of the clinical trial?
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What are the standard treatments for intraocular melanoma? Why do researchers think the new treatment may be better? What is likely to happen to me with or without the new treatment?
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What tests and treatments will I need? Will I need surgery? Medication? Hospitalization?
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How long will the treatment last? How often will I have to come back for follow-up exams?
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What are the treatment’s possible benefits to my condition? What are the short- and long-term risks? What are the possible side effects?
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Will the treatment be uncomfortable? Will it make me feel sick? If so, for how long?
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How will my health be monitored?
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Where will I need to go for the clinical trial? How will I get there?
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How much will it cost to be in the study? What costs are covered by the study? How much will my health insurance cover?
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Will I be able to see my own doctor? Who will be in charge of my care?
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Will taking part in the study affect my daily life? Do I have time to participate?
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How do I feel about taking part in a clinical trial? Are there family members or friends who may benefit from my contributions to new medical knowledge?
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Clinical Trials and Insurance Coverage21 As you consider enrolling in a clinical trial, you will face the critical issue of how to cover the costs of care. Even if you have health insurance, your coverage may not include some or all of the patient care costs associated with a clinical trial. This is because some health plans define clinical trials as “experimental” or “investigational” procedures. Because lack of coverage for these costs can keep people from enrolling in trials, the National Cancer Institute is working with major health plans and managed care groups to find solutions. In the meantime, there are strategies that may help you deal with cost and coverage barriers. This section answers frequently asked questions about insurance coverage for clinical trial participation and directs you to additional information resources. The material here is mainly concerned with treatment clinical trials, since other types of trials (prevention, screening, etc.) are newer and generally not covered by health insurance at all. However, this guide may become more relevant for prevention and other types of trials as these trials grow more common. If you do not have any health insurance, you may find this section helpful for understanding some of the costs that trials involve. What Costs Do Trials Involve? Who Is Usually Responsible for Paying Them? There are two types of costs associated with a trial: patient care costs and research costs. Patient care costs fall into two categories: ·
Usual care costs, such as doctor visits, hospital stays, clinical laboratory tests, x-rays, etc., which occur whether you are participating in a trial or receiving standard treatment. These costs have usually been covered by a third-party health plan, such as Medicare or private insurance.
·
Extra care costs associated with clinical trial participation, such as the additional tests that may or may not be fully covered by the clinical trial sponsor and/or research institution.
Adapted from the NCI: http://www.cancer.gov/clinical_trials/doc_header.aspx?viewid=1d92be79-8748-4bda-80052a56d332463b.
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The sponsor and the participant’s health plan need to resolve coverage of these costs for particular trials. Research costs are those associated with conducting the trial, such as data collection and management, research physician and nurse time, analysis of results, and tests purely performed for research purposes. Such costs are usually covered by the sponsoring organization, such as NCI or a pharmaceutical company.
Criteria Used by Health Plans to Make Reimbursement Decisions about Trials Health insurance companies and managed care companies decide which health care services they will pay for by developing coverage policy regarding the specific services. In general, the most important factor determining whether something is covered is a health plan’s judgment as to whether the service is established or investigational. Health plans usually designate a service as established if there is a certain amount of scientific data to show that it is safe and effective. If the health plan does not think that such data exist in sufficient quantity, the plan may label the service as investigational. Health care services delivered within the setting of a clinical trial are very often categorized as investigational and not covered. This is because the health plan thinks that the major reason to perform the clinical trial is that there is not enough data to establish the safety and effectiveness of the service being studied. Thus, for some health plans, any mention of the fact that the patient is involved in a clinical trial results in a denial of payment. Your health plan may define specific criteria that a trial must meet before extending coverage, such as the following:
Sponsorship Some plans may only cover costs of trials sponsored by organizations whose review and oversight of the trial is careful and scientifically rigorous, according to standards set by the health plan.
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Trial Phase and Type Some plans may cover patient care costs only for the clinical trials they judge to be “medically necessary” on a case-by-case basis. Trial phase may also affect coverage; for example, while a plan may be willing to cover costs associated with Phase III trials, which include treatments that have already been successful with a certain number of people, the plan may require some documentation of effectiveness before covering a Phase I or II trial. While health plans are interested in efforts to improve prevention and screening, they currently seem less likely to have a review process in place for these trials. Therefore, it may be more difficult to get coverage for the care costs associated with them. Some plans, especially smaller ones, will not cover any costs associated with a clinical trial. Policies vary widely, but in most cases your best bet is to have your doctor initiate discussions with the health plan. Cost “Neutrality” Some health plans may limit coverage to trials they consider cost-neutral (i.e., not significantly more expensive than the treatments considered standard). Lack of Standard Therapy Some plans limit coverage of trials to situations in which no standard therapy is available. Facility and Personnel Qualifications A health plan may require that the facility and medical staff meet specific qualifications to conduct a trial involving unique services, especially intensive therapy such as a bone marrow transplant (high-dose chemotherapy with bone marrow/ stem cell rescue).
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Clinical Trials and Medicare Coverage For up-to-date information about Medicare coverage of clinical trials, go to the Web site for the Centers for Medicaid & Medicare (http://www.hcfa.gov/coverage/8d.htm; formerly the Health Care Financing Administration). As of January 2001, the following information was accurate22: What Will Medicare Pay? ·
Anything normally covered is still covered when it is part of a clinical trial. This includes test, procedures, and doctor visits that are ordinarily covered.
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Anything normally covered even if it is a service or item associated with the experimental treatment. For example, Medicare will pay for the intravenous administration of a new chemotherapy drug being tested in a trial, including any therapy to prevent side effects from the new drug.
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Anything normally covered even if it resulted from your being in the clinical trial. For example, a test or hospitalization resulting from a side effect of the new treatment that Medicare would ordinarily cover. What Costs Are Not Covered?
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Investigational items or services being tested in a trial. Sponsors of clinical trials often provide the new drug free, but make sure you ask your doctor before you begin.
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Items or services used solely for the data collection needs of the trial.
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Anything being provided free by the sponsor of the trial. What Kinds of Clinical Trials Are Covered?
NCI’s Cancer Information Service has provided a fact sheet for Medicare beneficiaries at the following Web site: http://cis.nci.nih.gov/fact/8_14.htm. In general, cancer treatment and diagnosis trials are covered if: On June 7, 2000, Present Clinton announced that Medicare would revise its payment policy to reimburse the routine patient care costs of clinical trials. The announcement is available for public viewing at the following Web address: http://www.cancer.gov/clinical_trials/doc.aspx?viewid=320DD013-BA7A-4177-A0002011089F34A0.
22
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·
They are funded by the National Cancer Institute (NCI), NCI-Designated Cancer Centers, NCI-Sponsored Clinical Trials Cooperative Groups and all other Federal agencies that fund cancer research. Other trials may be eligible for coverage and doctors can ask Medicare to pay the patients’ costs. Ask your doctor about this before you begin.
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They are designed to treat or diagnose your cancer.
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The purpose or subject of the trial is within a Medicare benefit category. For example, cancer diagnosis and treatment are Medicare benefits, so these trials are covered. Cancer prevention trials are not currently covered.
Increasing the Likelihood of Insurance Coverage for Trials23 There are several steps you can follow to deal with coverage issues up front when deciding to enter a clinical trial. Along the way, enlist the help of family members and your doctor or other health professionals. You may find the following checklist useful:
Understand the Costs Associated with the Trial Ask your doctor or the trial’s contact person about the costs that must be covered by you or your health plan. Are these costs significantly higher than those associated with standard care? Also, inquire about the experience of other patients in the trial. Have their plans paid for their care? Have there been any persistent problems with coverage? How often have the trial’s administrators been successful in getting plans to cover patient care costs?
Understand Your Health Plan Be sure you know what’s in your policy; request and carefully review the actual contract language. If there’s a specific exclusion for “experimental treatment,” look closely at the policy to see how the plan defines such treatment and under what conditions it might be covered. If it is not clearly defined, call the plan’s customer service line, consult their Web site, and/or write to them. Ask for specific information about clinical trials coverage.
This section has been adapted from the NCI: http://www.cancer.gov/clinical_trials/doc_header.aspx?viewid=1d92be79-8748-4bda-80052a56d332463b&docid=0df4397a-eccb-465f-bd33-a89e7a708c46.
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Work Closely with Your Doctor Talk with your doctor about the paperwork he or she submits to your health plan. If there have been problems with coverage in the past, you might ask your doctor or the hospital to send an information package to the plan that includes studies supporting the procedure’s safety, benefits, and medical appropriateness. This package might include: ·
Publications from peer-reviewed literature about the proposed therapy that demonstrate patient benefits;
·
A letter that uses the insurance contract’s own language to explain why the treatment, screening method, or preventive measure should be covered;
·
Letters from researchers that explain the clinical trial;
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Support letters from patient advocacy groups.
Be sure to keep your own copy of any materials that the doctor sends to your health plan for future reference. Work Closely with Your Company’s Benefits Manager This person may be helpful in enlisting the support of your employer to request coverage by the health plan.
Give Your Health Plan a Deadline Ask the hospital or cancer center to set a target date for the therapy. This will help to ensure that coverage decisions are made promptly.
Know Your Rights24 A number of state governments are addressing the question of whether insurance companies ought to cover the costs associated with patients’ participation in clinical trials. Lack of such coverage is a significant barrier to many patients who might otherwise benefit from enrolling in a trial. Lack of coverage also makes it harder for researchers to successfully conduct trials that could improve prevention and treatment options. Information on State initiatives and legislation concerning cancer-related clinical trials is available 24
Adapted from Cancer.gov: http://www.cancer.gov/ClinicalTrials/insurancelaws.
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at http://www.cancer.gov/ClinicalTrials/insurancelaws. By conducting your own research and learning about your rights, you may increase the likelihood that your insurance company will cover the costs of a trial.
If Your Insurance Claim Is Denied after the Trial Has Begun If a claim is denied, read your policy to find out what steps you can follow to make an appeal. In “What Cancer Survivors Need to Know about Health Insurance”, the National Coalition for Cancer Survivorship suggests that you and your doctor demonstrate to the health plan that: ·
The therapy is not just a research study, but also a valid procedure that benefits patients;
·
Your situation is similar to that of other patients who are participating in clinical trials as part of a covered benefit;
·
Possible complications have been anticipated and can be handled effectively.
You also may wish to contact your state insurance counseling hotline or insurance department for more help, or write your state insurance commissioner describing the problem. Where Else Can I Turn for Assistance? It’s never easy to deal with financial issues when you or a loved one faces cancer. Unfortunately, costs can present a significant barrier to clinical trials participation. The range of insurance issues and health plan contracts makes it impossible to deal with all of them here. You may wish to consult this partial list of publications, organizations, and Web sites for more information: Publications What Cancer Survivors Need to Know about Health Insurance National Coalition of Cancer Survivorship 1010 Wayne Avenue, 5th floor Silver Spring, MD 20910 (301) 650-8868 http://www.cansearch.org/
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Cancer Treatments Your Insurance Should Cover The Association of Community Cancer Centers 11600 Nebel Street, Suite 201 Rockville, MD 20852 (301) 984-9496 http://www.accc-cancer.org/main2001.shtml The Managed Care Answer Guide Patient Advocate Foundation 739 Thimble Shoals Boulevard, Suite 704 Newport News, VA 23606 (757) 873-6668 E-mail:
[email protected] 1998 Guide to Health Insurance for People with Medicare, The Medicare Handbook Medicare Helpline: 1-800-444-4606 Health Care Financing Administration: http://www.hcfa.gov/ New Medicare site: http://www.medicare.gov/ Assistance Programs Candlelighters Childhood Cancer Foundation Ombudsman Program 910 Woodmont Avenue, #4607 Bethesda, MD 20814 (301) 657-8401; 1-800-366-2223 (toll-free) E-mail:
[email protected] http://www.candlelighters.org The Ombudsman Program helps families of children with cancer and survivors of childhood cancer resolve a range of problems, including insurance coverage difficulties. Local groups appoint a Parent Advocate who works with the treatment center on behalf of families. Medical Care Management Corporation 5272 River Road, Suite 650 Bethesda, MD 20816-1405 (301) 652-1818 email:
[email protected] http://www.mcman.com/ Working for a range of clients, including health plans, employers, and patients, MCMC conducts independent, objective reviews of high-
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technology medical care cases to assist in decision-making. While it does charge for its services, MCMC also offers a volunteer program for those who cannot afford to pay. More Information Resources OncoLink A service of the University of Pennsylvania Cancer Center. http://www.oncolink.com/ In addition to general cancer information, this web site features a section on financial information for patients. Among the topics: viatical settlements, life insurance, a glossary of financial and medical terms, and news about billing and insurance. American Association of Health Plans 1129 20th Street, NW, Suite 600 Washington, DC 20036-3421 (202) 778-3200 http://www.aahp.org/ The Web site section “For Consumers” includes a fact sheet on clinical research that describes various health plans’ efforts to support research initiatives and collaborate with academic health centers and universities. Health Insurance Association of America 555 13th Street, NW Washington, DC 20004 (202) 824-1600 ·
Home page: http://www.hiaa.org/
·
Consumer Information: http://www.hiaa.org/consumer/
·
Insurance Counseling Hotlines by State: http://www.hiaa.org/consumer/insurance_counsel.cfm
·
State Insurance Departments: http://www.hiaa.org/consumer/state_insurance.cfm
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Government Initiatives to Expand Insurance Coverage for Trials25 The good news is that there has been a recent effort in the U.S. to assure clinical trials coverage, with NCI involved in several new initiatives as described below: NCI-Department of Defense Agreement An innovative 1996 agreement between NCI and the Department of Defense (DoD) has given thousands of DoD cancer patients more options for care and greater access to state-of-the-art treatments. Patients who are beneficiaries of TRICARE/CHAMPUS, the DoD’s health program, are covered for NCIsponsored Phase II and Phase III clinical treatment trials. NCI and DoD are refining a system that allows physicians and patients to determine quickly what current trials meet their needs and where they are taking place. NCI-Department of Veterans Affairs Agreement A 1997 agreement with the Department of Veterans Affairs provides coverage for eligible veterans of the armed services to participate in NCIsponsored prevention, diagnosis, and treatment studies nationwide. For additional information, see the VA/DoD Beneficiaries Digest Page at http://www.va.gov/cancer.htm.
Midwest Health Plans Agreement Some NCI Cooperative Groups have reached agreements with several insurers in Wisconsin and Minnesota to provide more than 200,000 people with coverage. This coverage is allocated for patient care costs if they participate in a cooperative group-sponsored trial.
Adapted from the NCI: http://www.cancer.gov/clinical_trials/doc_header.aspx?viewid=1d92be79-8748-4bda-80052a56d332463b&docid=d8092601-daf9-4794-8536-3be2712eb6b9.
25
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Pediatric Cancer Care Network This network, a cooperative agreement among the Children’s Cancer Group, the Pediatric Oncology Group, and the Blue Cross Blue Shield System Association (BCBS) nationwide, will ensure that children of BCBS subscribers receive care at designated centers of cancer care excellence and may promote the enrollment of children in Cooperative Group clinical trials.
Keeping Current on Clinical Trials Various government agencies maintain databases on trials. The U.S. National Institutes of Health, through the National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and physicians with current information about clinical research across the broadest number of diseases and conditions. The site was launched in February 2000 and currently contains approximately 5,700 clinical studies in over 59,000 locations worldwide, with most studies being conducted in the United States. ClinicalTrials.gov receives about 2 million hits per month and hosts approximately 5,400 visitors daily. To access this database, simply go to their Web site (www.clinicaltrials.gov) and search by “intraocular melanoma” (or synonyms). While ClinicalTrials.gov is the most comprehensive listing of NIH-supported clinical trials available, not all trials are in the database. The database is updated regularly, so clinical trials are continually being added. The following is a list of specialty databases affiliated with the National Institutes of Health that offer additional information on trials: ·
For clinical studies at the Warren Grant Magnuson Clinical Center located in Bethesda, Maryland, visit their Web site: http://clinicalstudies.info.nih.gov/
·
For clinical studies conducted at the Bayview Campus in Baltimore, Maryland, visit their Web site: http://www.jhbmc.jhu.edu/studies/index.html
·
For cancer trials, visit the National Cancer Institute: http://cancertrials.nci.nih.gov/
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General References The following references describe clinical trials and experimental medical research. They have been selected to ensure that they are likely to be available from your local or online bookseller or university medical library. These references are usually written for healthcare professionals, so you may consider consulting with a librarian or bookseller who might recommend a particular reference. The following includes some of the most readily available references (sorted alphabetically by title; hyperlinks provide rankings, information and reviews at Amazon.com): ·
A Guide to Patient Recruitment : Today’s Best Practices & Proven Strategies by Diana L. Anderson; Paperback - 350 pages (2001), CenterWatch, Inc.; ISBN: 1930624115; http://www.amazon.com/exec/obidos/ASIN/1930624115/icongroupinterna
·
A Step-By-Step Guide to Clinical Trials by Marilyn Mulay, R.N., M.S., OCN; Spiral-bound - 143 pages Spiral edition (2001), Jones & Bartlett Pub; ISBN: 0763715697; http://www.amazon.com/exec/obidos/ASIN/0763715697/icongroupinterna
·
The CenterWatch Directory of Drugs in Clinical Trials by CenterWatch; Paperback - 656 pages (2000), CenterWatch, Inc.; ISBN: 0967302935; http://www.amazon.com/exec/obidos/ASIN/0967302935/icongroupinterna
·
The Complete Guide to Informed Consent in Clinical Trials by Terry Hartnett (Editor); Paperback - 164 pages (2000), PharmSource Information Services, Inc.; ISBN: 0970153309; http://www.amazon.com/exec/obidos/ASIN/0970153309/icongroupinterna
·
Dictionary for Clinical Trials by Simon Day; Paperback - 228 pages (1999), John Wiley & Sons; ISBN: 0471985961; http://www.amazon.com/exec/obidos/ASIN/0471985961/icongroupinterna
·
Extending Medicare Reimbursement in Clinical Trials by Institute of Medicine Staff (Editor), et al; Paperback 1st edition (2000), National Academy Press; ISBN: 0309068886; http://www.amazon.com/exec/obidos/ASIN/0309068886/icongroupinterna
·
Handbook of Clinical Trials by Marcus Flather (Editor); Paperback (2001), Remedica Pub Ltd; ISBN: 1901346293; http://www.amazon.com/exec/obidos/ASIN/1901346293/icongroupinterna
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Vocabulary Builder The following vocabulary builder gives definitions of words used in this chapter that have not been defined in previous chapters: Alum: A type of immune adjuvant (a substance used to help boost the immune response to a vaccine). Also called aluminum sulfate. [NIH] Amifostine: A drug used as a chemoprotective drug to control some of the side effects of chemotherapy and radiation therapy. [NIH] Analog: In chemistry, a substance that is similar, but not identical, to another. [NIH] Anemia: A condition in which the number of red blood cells is below normal. [NIH] Antibiotic: A drug used to treat infections caused by bacteria and other microorganisms. [NIH] Antibody: A type of protein made by certain white blood cells in response to a foreign substance (antigen). Each antibody can bind to only a specific antigen. The purpose of this binding is to help destroy the antigen. Antibodies can work in several ways, depending on the nature of the antigen. Some antibodies destroy antigens directly. Others make it easier for white blood cells to destroy the antigen. [NIH] Azacitidine: An anticancer drug that belongs to the family of drugs called antimetabolites. [NIH] Biopsy: The removal of cells or tissues for examination under a microscope. When only a sample of tissue is removed, the procedure is called an incisional biopsy or core biopsy. When an entire tumor or lesion is removed, the procedure is called an excisional biopsy. When a sample of tissue or fluid is removed with a needle, the procedure is called a needle biopsy or fineneedle aspiration. [NIH] Brachytherapy: A procedure in which radioactive material sealed in needles, seeds, wires, or catheters is placed directly into or near a tumor. Also called internal radiation, implant radiation, or interstitial radiation therapy. [NIH] Busulfan: An anticancer drug that belongs to the family of drugs called alkylating agents. [NIH] Carboplatin: An anticancer drug that belongs to the family of drugs called platinum compounds. [NIH] Carcinoma: Cancer that begins in the skin or in tissues that line or cover internal organs. [NIH]
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Cardiac: Having to do with the heart. [NIH] Chemoprotective: A quality of some drugs used in cancer treatment. Chemoprotective agents protect healthy tissue from the toxic effects of anticancer drugs. [NIH] Cisplatin: An anticancer drug that belongs to the family of drugs called platinum compounds. [NIH] CNS: Central nervous system. The brain and spinal cord. [NIH] Enzyme: A protein that speeds up chemical reactions in the body. [NIH] Epithelial: Refers to the cells that line the internal and external surfaces of the body. [NIH] Filgrastim: A colony-stimulating factor that stimulates the production of neutrophils (a type of white blood cell). It is a cytokine that belongs to the family of drugs called hematopoietic (blood-forming) agents. Also called granulocyte colony-stimulating factor (G-CSF). [NIH] Flavopiridol: Belongs to the family of anticancer drugs called flavinols. [NIH] Granulocytopenia: A deficiency in the number of granulocytes, a type of white blood cell. [NIH] Immunization: The induction of immunity. [EU] Interferon: A biological response modifier (a substance that can improve the body's natural response to disease). Interferons interfere with the division of cancer cells and can slow tumor growth. There are several types of interferons, including interferon-alpha, -beta, and -gamma. These substances are normally produced by the body. They are also made in the laboratory for use in treating cancer and other diseases. [NIH] Intrathecal: Describes the fluid-filled space between the thin layers of tissue that cover the brain and spinal cord. Drugs can be injected into the fluid or a sample of the fluid can be removed for testing. [NIH] Invasive: 1. having the quality of invasiveness. 2. involving puncture or incision of the skin or insertion of an instrument or foreign material into the body; said of diagnostic techniques. [EU] Irinotecan: An anticancer drug that belongs to a family of anticancer drugs called topoisomerase inhibitors. It is a camptothecin analogue. Also called CPT 11. [NIH] Leukemia: Cancer of blood-forming tissue. [NIH] Levofloxacin: A substance used to treat bacterial infections. It belongs to the family of drugs called quinolone antibiotics. [NIH] Liposomal: A drug preparation that contains the active drug in very tiny fat particles. This fat-encapsulated drug is absorbed better, and its distribution to the tumor site is improved. [NIH]
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Liver: A large, glandular organ located in the upper abdomen. The liver cleanses the blood and aids in digestion by secreting bile. [NIH] Lymphoma: Cancer that arises in cells of the lymphatic system. [NIH] Metastatic: Having to do with metastasis, which is the spread of cancer from one part of the body to another. [NIH] Myeloma: Cancer that arises in plasma cells, a type of white blood cell. [NIH] Neoplasm: A new growth of benign or malignant tissue. [NIH] Neuroblastoma: Cancer that arises in immature nerve cells and affects mostly infants and children. [NIH] Peptide: Any compound consisting of two or more amino acids, the building blocks of proteins. Peptides are combined to make proteins. [NIH] Phenylbutyrate: An anticancer drug that belongs to the family of drugs called differentiating agents. [NIH] Plasmapheresis: The process of separating certain cells from the plasma in the blood by a machine; only the cells are returned to the person. Plasmapheresis can be used to remove excess antibodies from the blood. [NIH] Preoperative: Preceding an operation. [EU] Progressive: Advancing; going forward; going from bad to worse; increasing in scope or severity. [EU] Proteins: Polymers of amino acids linked by peptide bonds. The specific sequence of amino acids determines the shape and function of the protein. [NIH]
Pyrazoloacridine: An anticancer drug that belongs to the family of drugs called acridines. [NIH] Randomized: Describes an experiment or clinical trial in which animal or human subjects are assigned by chance to separate groups that compare different treatments. [NIH] Rebeccamycin: An anticancer drug that belongs to the family of drugs called antineoplastic antibiotics. [NIH] Refractory: Not readily yielding to treatment. [EU] Regimen: A treatment plan that specifies the dosage, the schedule, and the duration of treatment. [NIH] Sarcoma: A cancer of the bone, cartilage, fat, muscle, blood vessels or other connective or supportive tissue. [NIH] Sargramostim: A colony-stimulating factor that stimulates the production of blood cells, especially platelets, during chemotherapy. It is a cytokine that belongs to the family of drugs called hematopoietic (blood-forming) agents. Also called GM-CSF. [NIH]
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STI571: A drug that is being studied for its ability to inhibit the growth of certain cancers. It interferes with a portion of the protein produced by the bcr/abl oncogene. [NIH] Temozolomide: An anticancer drug that belongs to the family of drugs called alkylating agents. [NIH] Testicular: Pertaining to a testis. [EU] Thalidomide: A drug that belongs to the family of drugs called angiogenesis inhibitors. It prevents the growth of new blood vessels into a solid tumor. [NIH] Thiotepa: An anticancer drug that belongs to the family of drugs called alkylating agents. [NIH] Topotecan: An anticancer drug that belongs to the family drugs called topoisomerase inhibitors. [NIH] Transplantation: person. [NIH]
The replacement of an organ with one from another
Urine: Fluid containing water and waste products. Urine is made by the kidneys, stored in the bladder, and leaves the body through the urethra. [NIH] Uveitis: An inflammation of part or all of the uvea, the middle (vascular) tunic of the eye, and commonly involving the other tunics (the sclera and cornea, and the retina). [EU] Vaccination: Treatment with a vaccine. [NIH] Vaccine: A substance or group of substances meant to cause the immune system to respond to a tumor or to microorganisms, such as bacteria or viruses. [NIH] Vitreous: Glasslike or hyaline; often used alone to designate the vitreous body of the eye (corpus vitreum). [EU]
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PART II: ADDITIONAL RESOURCES AND ADVANCED MATERIAL
ABOUT PART II In Part II, we introduce you to additional resources and advanced research on intraocular melanoma. All too often, patients who conduct their own research are overwhelmed by the difficulty in finding and organizing information. The purpose of the following chapters is to provide you an organized and structured format to help you find additional information resources on intraocular melanoma. In Part II, as in Part I, our objective is not to interpret the latest advances on intraocular melanoma or render an opinion. Rather, our goal is to give you access to original research and to increase your awareness of sources you may not have already considered. In this way, you will come across the advanced materials often referred to in pamphlets, books, or other general works. Once again, some of this material is technical in nature, so consultation with a professional familiar with intraocular melanoma is suggested.
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CHAPTER 4. STUDIES ON INTRAOCULAR MELANOMA Overview Every year, academic studies are published on intraocular melanoma or related conditions. Broadly speaking, there are two types of studies. The first are peer reviewed. Generally, the content of these studies has been reviewed by scientists or physicians. Peer-reviewed studies are typically published in scientific journals and are usually available at medical libraries. The second type of studies is non-peer reviewed. These works include summary articles that do not use or report scientific results. These often appear in the popular press, newsletters, or similar periodicals. In this chapter, we will show you how to locate peer-reviewed references and studies on intraocular melanoma. We will begin by discussing research that has been summarized and is free to view by the public via the Internet. We then show you how to generate a bibliography on intraocular melanoma and teach you how to keep current on new studies as they are published or undertaken by the scientific community.
Federally Funded Research on Intraocular Melanoma The U.S. Government supports a variety of research studies relating to intraocular melanoma and associated conditions. These studies are tracked by the Office of Extramural Research at the National Institutes of Health.26 26 Healthcare projects are funded by the National Institutes of Health (NIH), Substance Abuse and Mental Health Services (SAMHSA), Health Resources and Services Administration (HRSA), Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDCP), Agency for Healthcare Research and Quality (AHRQ), and Office of Assistant Secretary of Health (OASH).
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CRISP (Computerized Retrieval of Information on Scientific Projects) is a searchable database of federally funded biomedical research projects conducted at universities, hospitals, and other institutions. Visit the CRISP Web site at http://commons.cit.nih.gov/crisp3/CRISP.Generate_Ticket. You can perform targeted searches by various criteria including geography, date, as well as topics related to intraocular melanoma and related conditions. For most of the studies, the agencies reporting into CRISP provide summaries or abstracts. As opposed to clinical trial research using patients, many federally funded studies use animals or simulated models to explore intraocular melanoma and related conditions. In some cases, therefore, it may be difficult to understand how some basic or fundamental research could eventually translate into medical practice. The following sample is typical of the type of information found when searching the CRISP database for intraocular melanoma: ·
Project Title: Conformal Radioactive Plaques for Intraocular Melanoma Principal Investigator & Institution: Sioshansi, Piran I.; Vice President; Radiomed Corporation 9 Linnell Cir Billerica, Ma 01821 Timing: Fiscal Year 2000; Project Start 1-APR-1998; Project End 1-AUG2002 Summary: Radiation is the most frequently used eye and vision-sparing alternative to enucleation of eyes with choroidal melanoma. Brachytherapy, in the form of ophthalmic (radioactive) plaques (OP) is a successful approach for treatment of choroidal melanoma. While preserving vision and minimizing complications, ophthalmic plaque radiotherapy has offered excellent (>92%) local control rates. Current generation ophthalmic plaques, 60Co, 106Ru plates,125I, and 103pd seeds, are less than ideal for dose delivery, have a primitive design, involve antiquated and inefficient manufacturing procedures, and suffer from one or more deficiencies. We propose developing a new ophthalmic plaque based on a charged particle activation process, which allows for manufacturing a broad uniform source, directly embedded in a thin foil. This technology allows for automated custom manufacturing of OPs that match the source intensity to the topography of tumor. Such conformal radiation ophthalmic plaques (CROP) will maximize the tumor dose and minimize the unintentional dose to neighboring radiosensitive tissues. The Phase I application demonstrated feasibility of the process. Tearing arrangements have been made with a leading ophthalmologist and one of the champions of brachytherapy by OP to evaluate the clinical performance of the conformal radiation ophthalmic plaques and demonstrate the success of the project. Proposed Commercial
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Application: The market for ophthalmic plaques is small. The U.S. market for such a product is estimated to be around 1500 units/year. There are an equal number of patients overseas. If we assume each plaque uses up to 40 seeds at an average cost of $50 per seed and the associated assembly costs to be approximately $3000, the potential market for new generation OPs is $4,500,000 in the U.S. There is a market of approximately equal size for infants suffering from retinoblastoma where there is a dire need for a thin ophthalmic plaque. There is a sizeable potential market for the OPs for treatment of age related neovascularization. Website: http://commons.cit.nih.gov/crisp3/CRISP.Generate_Ticket
The National Library of Medicine: PubMed One of the quickest and most comprehensive ways to find academic studies in both English and other languages is to use PubMed, maintained by the National Library of Medicine. The advantage of PubMed over previously mentioned sources is that it covers a greater number of domestic and foreign references. It is also free to the public.27 If the publisher has a Web site that offers full text of its journals, PubMed will provide links to that site, as well as to sites offering other related data. User registration, a subscription fee, or some other type of fee may be required to access the full text of articles in some journals. To generate your own bibliography of studies dealing with intraocular melanoma, simply go to the PubMed Web site at www.ncbi.nlm.nih.gov/pubmed. Type “intraocular melanoma” (or synonyms) into the search box, and click “Go.” The following is the type of output you can expect from PubMed for “intraocular melanoma” (hyperlinks lead to article summaries): ·
A method for assessing potential bias among cancer patients recorded as "dead of other causes." Application to cases of intraocular melanoma. Author(s): Gamel J, Seddon J, Polivogianis L, Albert D, Greenberg R.
PubMed was developed by the National Center for Biotechnology Information (NCBI) at the National Library of Medicine (NLM) at the National Institutes of Health (NIH). The PubMed database was developed in conjunction with publishers of biomedical literature as a search tool for accessing literature citations and linking to full-text journal articles at Web sites of participating publishers. Publishers that participate in PubMed supply NLM with their citations electronically prior to or at the time of publication.
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Source: Cancer. 1986 June 1; 57(11): 2246-9. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=3697925&dopt=Abstract ·
A method for determining the optimum transform for covariates of the Cox model with application to 3680 cases of intraocular melanoma. Author(s): Gamel JW, McLean IW. Source: Computers and Biomedical Research, an International Journal. 1988 October; 21(5): 471-7. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=3180746&dopt=Abstract
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A simple cytologic method for predicting the malignant potential of intraocular melanoma. Author(s): Huntington A, Haugan P, Gamel J, McLean I. Source: Pathology, Research and Practice. 1989 November; 185(5): 631-4. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=2696944&dopt=Abstract
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Anterior vs posterior intraocular melanoma. Metastatic differences in a murine model. Author(s): Grossniklaus HE, Wilson MW, Barron BC, Lynn MJ. Source: Archives of Ophthalmology. 1996 September; 114(9): 1116-20. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=8790099&dopt=Abstract
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Biologic distinctions between cure and time to death in 2892 patients with intraocular melanoma. Author(s): Gamel JW, McLean IW, McCurdy JB. Source: Cancer. 1993 April 1; 71(7): 2299-305. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=8453550&dopt=Abstract
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Congenital intraocular melanoma in a calf. Author(s): Schuh JC. Source: Journal of Comparative Pathology. 1989 July; 101(1): 113-6. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=2794149&dopt=Abstract
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Detection and quantification of S-100 protein in ocular tissues and fluids from patients with intraocular melanoma.
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Author(s): Cochran AJ, Holland GN, Saxton RE, Damato BE, Foulds WR, Herschman HR, Foos RY, Straatsma BR, Lee WR. Source: The British Journal of Ophthalmology. 1988 November; 72(11): 874-9. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=3207666&dopt=Abstract ·
Echographic differentiation of histological types of intraocular melanoma. Author(s): Thijssen JM, Verbeek AM, Romijn RL, de Wolff-Rouendaal D, Oosterhuis JA. Source: Ultrasound in Medicine & Biology. 1991; 17(2): 127-38. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=2053209&dopt=Abstract
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Efficacy of dacarbazine (DTIC) in preventing metastases arising from intraocular melanomas in mice. Author(s): Sanborn GE, Niederkorn JY, Gamel JW. Source: Graefe's Archive for Clinical and Experimental Ophthalmology = Albrecht Von Graefes Archiv Fur Klinische Und Experimentelle Ophthalmologie. 1992; 230(2): 192-6. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=1577304&dopt=Abstract
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Enucleation in consort with immunologic impairment promotes metastasis of intraocular melanomas in mice. Author(s): Niederkorn JY. Source: Investigative Ophthalmology & Visual Science. 1984 September; 25(9): 1080-6. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=6381375&dopt=Abstract
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Enucleation-induced metastasis of intraocular melanomas in mice. Author(s): Niederkorn JY. Source: Ophthalmology. 1984 June; 91(6): 692-700. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=6462628&dopt=Abstract
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Epidemiology of intraocular melanoma. Author(s): Tucker MA, Hartge P, Shields JA.
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Source: Recent Results Cancer Res. 1986; 102: 159-65. No Abstract Available. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=3738184&dopt=Abstract ·
Evaluation of closed loop control of arterial pressure during hypotensive anaesthesia for local resection of intraocular melanoma. Author(s): Chaudhri S, Colvin JR, Todd JG, Kenny GN. Source: British Journal of Anaesthesia. 1992 December; 69(6): 607-10. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=1467105&dopt=Abstract
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Experimental model for metastasis of intraocular melanoma: preventive role of natural killer cells. Author(s): Yokoyama T, Yoshie O, Mizuno K. Source: Japanese Journal of Ophthalmology. 1989; 33(1): 76-84. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=2733256&dopt=Abstract
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Familial intraocular melanoma. Author(s): Tasman W. Source: Trans Am Acad Ophthalmol Otolaryngol. 1970 SeptemberOctober; 74(5): 955-8. No Abstract Available. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=5506870&dopt=Abstract
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Interval-by-interval Cox model analysis of 3680 cases of intraocular melanoma shows a decline in the prognostic value of size and cell type over time after tumor excision. Author(s): Gamel JW, McLean IW, Greenberg RA. Source: Cancer. 1988 February 1; 61(3): 574-9. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=3338025&dopt=Abstract
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Intraocular melanoma in a horse. Author(s): Murphy J, Young S. Source: Vet Pathol. 1979 September; 16(5): 539-42. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=473483&dopt=Abstract
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Intraocular melanoma in an alpaca. Author(s): Hamor RE, Severin GA, Roberts SM.
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Source: Veterinary Ophthalmology. 1999; 2(3): 193-196. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=11397265&dopt=Abstract ·
Intraocular melanoma in the rat. Author(s): Magnusson G, Majeed S, Offer JM. Source: Laboratory Animals. 1978 October; 12(4): 249-52. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=732271&dopt=Abstract
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Intraocular melanoma linked to occupations and chemical exposures. Author(s): Holly EA, Aston DA, Ahn DK, Smith AH. Source: Epidemiology (Cambridge, Mass.). 1996 January; 7(1): 55-61. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=8664402&dopt=Abstract
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Intraocular melanoma spread to regional lymph nodes: report of two cases. Author(s): Dithmar S, Diaz CE, Grossniklaus HE. Source: Retina (Philadelphia, Pa.). 2000; 20(1): 76-9. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=10696752&dopt=Abstract
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Intraocular melanoma with multiple metastases in a cat. Author(s): Bertoy RW, Brightman AH, Regan K. Source: J Am Vet Med Assoc. 1988 January 1; 192(1): 87-9. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=3343189&dopt=Abstract
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Intraocular melanoma, diabetes, and Turner's syndrome: presentation with proptosis. Author(s): Buckley CA, Cheng H. Source: The British Journal of Ophthalmology. 1981 July; 65(7): 460-3. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=7260020&dopt=Abstract
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Lack of association between intraocular melanoma and cutaneous dysplastic nevi. Author(s): Taylor MR, Guerry D 4th, Bondi EE, Shields JA, Augsburger JJ, Lusk EJ, Elder DE, Clark WH Jr, Van Horn M.
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Source: American Journal of Ophthalmology. 1984 October 15; 98(4): 47882. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=6486223&dopt=Abstract ·
Local resection and other conservative therapies for intraocular melanoma. Author(s): Foulds WS. Source: Current Opinion in Ophthalmology. 1995 June; 6(3): 62-9. Review. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=10150872&dopt=Abstract
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Management of exudative retinal detachment after plaque therapy for intraocular melanoma. Author(s): Radtke ND, Augsburger JJ, Schmitt T. Source: American Journal of Ophthalmology. 1991 July 15; 112(1): 92-4. No Abstract Available. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=1882929&dopt=Abstract
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Management of intraocular melanoma. Author(s): Foulds WS. Source: The British Journal of Ophthalmology. 1990 September; 74(9): 559-60. Review. No Abstract Available. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=2203470&dopt=Abstract
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Management of Irish patients with intraocular melanoma referred to Liverpool, England. Author(s): Kent D, Noonan CP, Damato BE. Source: Acta Ophthalmologica Scandinavica. 1998 October; 76(5): 584-8. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=9826044&dopt=Abstract
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Microwave thermoradiotherapy for intraocular melanoma. Author(s): Finger PT. Source: American Journal of Clinical Oncology : the Official Publication of the American Radium Society. 1996 June; 19(3): 281-9. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=8638542&dopt=Abstract
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Morphologic effects of bacteriochlorin a and light in vivo on intraocular melanoma. Author(s): Schuitmaker JJ, Vrensen GF, van Delft JL, de Wolff-Rouendaal D, Dubbelman TM, de Wolf A. Source: Investigative Ophthalmology & Visual Science. 1991 September; 32(10): 2683-8. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=1894468&dopt=Abstract
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Mouse model of brachytherapy in consort with enucleation for treatment of malignant intraocular melanoma. Author(s): Niederkorn J, Sanborn GE, Scarbrough EE. Source: Archives of Ophthalmology. 1990 June; 108(6): 865-8. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=2350289&dopt=Abstract
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Photodynamic therapy for experimental intraocular melanoma using chloroaluminum sulfonated phthalocyanine. Author(s): Panagopoulos JA, Svitra PP, Puliafito CA, Gragoudas ES. Source: Archives of Ophthalmology. 1989 June; 107(6): 886-90. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=2730407&dopt=Abstract
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Preventable delays in the treatment of intraocular melanoma in the UK. Author(s): Holden R, Damato BE. Source: Eye (London, England). 1996; 10 ( Pt 1): 127-9. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=8763318&dopt=Abstract
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Prevention of metastasis of intraocular melanoma in mice treated with difluoromethylornithine. Author(s): Sanborn G, Niederkorn J, Kan-Mitchell J, Albert D. Source: Graefe's Archive for Clinical and Experimental Ophthalmology = Albrecht Von Graefes Archiv Fur Klinische Und Experimentelle Ophthalmologie. 1992; 230(1): 72-7. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=1547972&dopt=Abstract
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Reduction of enucleation-induced metastasis in intraocular melanoma by periorbital irradiation. Author(s): Sanborn GE, Nguyen P, Gamel J, Niederkorn JY, Ngyuen P.
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Source: Archives of Ophthalmology. 1987 September; 105(9): 1260-4. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=3632444&dopt=Abstract ·
Reproducibility of nucleolar measurements in human intraocular melanoma cells on standard histologic microslides. Author(s): Gamel JW, Gleason J, Williams H, Greenberg R. Source: Anal Quant Cytol Histol. 1985 September; 7(3): 174-7. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=3902048&dopt=Abstract
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Risk factors for intraocular melanoma and occupational exposure. Author(s): Lutz JM, Cree IA, Foss AJ. Source: The British Journal of Ophthalmology. 1999 October; 83(10): 11903. Review. No Abstract Available. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=10502585&dopt=Abstract
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Role of epidermal growth factor receptor in the metastasis of intraocular melanomas. Author(s): Ma D, Niederkorn JY. Source: Investigative Ophthalmology & Visual Science. 1998 June; 39(7): 1067-75. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=9620065&dopt=Abstract
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Role of natural killer cells in intraocular melanoma metastasis. Author(s): Yokoyama T, Yoshie O, Aso H, Ebina T, Ishida N, Mizuno K. Source: Investigative Ophthalmology & Visual Science. 1986 April; 27(4): 516-8. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=3957568&dopt=Abstract
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T cell subsets involved in the rejection of metastases arising from intraocular melanomas in mice. Author(s): Niederkorn JY. Source: Investigative Ophthalmology & Visual Science. 1987 August; 28(8): 1397-403. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=3497133&dopt=Abstract
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The familial occurrence of cutaneous melanoma, intraocular melanoma, and the dysplastic nevus syndrome. Author(s): Fusaro RM, Lynch HT, Oosterhuis JA, Went LN. Source: American Journal of Ophthalmology. 1984 June; 97(6): 802-3. No Abstract Available. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=6731557&dopt=Abstract
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Tumor vascularity and hematogenous metastasis in experimental murine intraocular melanoma. Author(s): Grossniklaus HE. Source: Trans Am Ophthalmol Soc. 1998; 96: 721-52. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=10360307&dopt=Abstract
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Unilateral exophthalmos due to orbital metastasis from a contralateral intraocular melanoma. Author(s): Fujii K, Komurasaki Y, Kanno Y, Ohgou N. Source: Eur J Dermatol. 1998 July-August; 8(5): 343-6. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=9683861&dopt=Abstract
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A new technique for implantation of tissue culture melanoma cells in a murine model of metastatic ocular melanoma. Author(s): Dithmar S, Rusciano D, Grossniklaus HE. Source: Melanoma Research. 2000 February; 10(1): 2-8. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=10711634&dopt=Abstract
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Depletion of NK cell activity results in growth of hepatic micrometastases in a murine ocular melanoma model. Author(s): Dithmar SA, Rusciano DA, Armstrong CA, Lynn MJ, Grossniklaus HE. Source: Current Eye Research. 1999 November; 19(5): 426-31. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=10520219&dopt=Abstract
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Iris color as a prognostic factor in ocular melanoma. Author(s): Regan S, Judge HE, Gragoudas ES, Egan KM.
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Source: Archives of Ophthalmology. 1999 June; 117(6): 811-4. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=10369595&dopt=Abstract ·
Neoadjuvant interferon alfa-2b treatment in a murine model for metastatic ocular melanoma: a preliminary study. Author(s): Dithmar S, Rusciano D, Lynn MJ, Lawson DH, Armstrong CA, Grossniklaus HE. Source: Archives of Ophthalmology. 2000 August; 118(8): 1085-9. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=10922203&dopt=Abstract
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Noncontact detection of ocular melanoma with L-3-123I-iodo-alphamethyltyrosine: first clinical results. Author(s): Bockslaff H, Kloster G, Dausch D, Schad K, Hundeshagen H. Source: Graefe's Archive for Clinical and Experimental Ophthalmology = Albrecht Von Graefes Archiv Fur Klinische Und Experimentelle Ophthalmologie. 1982; 219(3): 149-54. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=7173627&dopt=Abstract
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Ocular melanoma with retinal detachment: double density sign on CT. Author(s): D'Altorio RA, Budde RB Jr. Source: Computerized Medical Imaging and Graphics : the Official Journal of the Computerized Medical Imaging Society. 1988 May-June; 12(3): 177-8. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=3409197&dopt=Abstract
Vocabulary Builder Arterial: Pertaining to an artery or to the arteries. [EU] Contralateral: Having to do with the opposite side of the body. [NIH] Cutaneous: Having to do with the skin. [NIH] Dacarbazine: An anticancer drug that belongs to the family of drugs called alkylating agents. [NIH] Difluoromethylornithine: DFMO. An anticancer drug that has been shown to reduce the risk of cancer in animals. [NIH] Epidermal: Pertaining to or resembling epidermis. Called also epidermic or epidermoid. [EU]
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Exophthalmos: Abnormal protrusion of the eyeball; called also proptosis. [EU]
Hematogenous: bloodstream. [NIH]
Originating in the blood or spread through the
Hepatic: Refers to the liver. [NIH] Hypotensive: Characterized by or causing diminished tension or pressure, as abnormally low blood pressure. [EU] Implantation: The insertion or grafting into the body of biological, living, inert, or radioactive material. [EU] Metastasis: The spread of cancer from one part of the body to another. Tumors formed from cells that have spread are called "secondary tumors" and contain cells that are like those in the original (primary) tumor. The plural is metastases. [NIH] Ophthalmic: Pertaining to the eye. [EU] Ophthalmology: A surgical specialty concerned with the structure and function of the eye and the medical and surgical treatment of its defects and diseases. [NIH] Particle: A tiny mass of material. [EU] Periorbital: Situated around the orbit, or eye socket. [EU] Posterior: Situated in back of, or in the back part of, or affecting the back or dorsal surface of the body. In lower animals, it refers to the caudal end of the body. [EU] Proptosis: Forward projection or displacement especially of the eyeball : exophthalmos. [EU] Radioactive: Giving off radiation. [NIH] Radiotherapy: The treatment of disease by ionizing radiation. [EU] Radium: Radium. A radioactive element of the alkaline earth series of metals. It has the atomic symbol Ra, atomic number 88, and atomic weight 226. Radium is the product of the disintegration of uranium and is present in pitchblende and all ores containing uranium. It is used clinically as a source of beta and gamma-rays in radiotherapy, particularly brachytherapy. [NIH] Receptor: A molecule inside or on the surface of a cell that binds to a specific substance and causes a specific physiologic effect in the cell. [NIH] Resection: Removal of tissue or part or all of an organ by surgery. [NIH] Retinoblastoma: An eye cancer that most often occurs in children younger than 5 years. It occurs in hereditary and nonhereditary (sporadic) forms. [NIH]
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CHAPTER 5. BOOKS ON INTRAOCULAR MELANOMA Overview This chapter provides bibliographic book references relating to intraocular melanoma. You have many options to locate books on intraocular melanoma. The simplest method is to go to your local bookseller and inquire about titles that they have in stock or can special order for you. Some patients, however, feel uncomfortable approaching their local booksellers and prefer online sources (e.g. www.amazon.com and www.bn.com). In addition to online booksellers, excellent sources for book titles on intraocular melanoma include the Combined Health Information Database and the National Library of Medicine. Once you have found a title that interests you, visit your local public or medical library to see if it is available for loan.
The National Library of Medicine Book Index The National Library of Medicine at the National Institutes of Health has a massive database of books published on healthcare and biomedicine. Go to the following Internet site, http://locatorplus.gov/, and then select “Search LOCATORplus.” Once you are in the search area, simply type “intraocular melanoma” (or synonyms) into the search box, and select “books only.” From there, results can be sorted by publication date, author, or relevance. The following was recently catalogued by the National Library of Medicine:28 In addition to LOCATORPlus, in collaboration with authors and publishers, the National Center for Biotechnology Information (NCBI) is adapting biomedical books for the Web. The books may be accessed in two ways: (1) by searching directly using any search term or phrase (in the same way as the bibliographic database PubMed), or (2) by following the links to PubMed abstracts. Each PubMed abstract has a “Books” button that displays a facsimile of the abstract in which some phrases are hypertext links. These phrases are also
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Intraocular tumors. Author: [edited by] Gholam A. Peyman, David J. Apple, Donald R. Sanders; Year: 1977; New York: Appleton/Century/Crofts, 1977; ISBN: 0838543022 http://www.amazon.com/exec/obidos/ASIN/0838543022/icongroupin terna
Chapters on Intraocular Melanoma Frequently, intraocular melanoma will be discussed within a book, perhaps within a specific chapter. In order to find chapters that are specifically dealing with intraocular melanoma, an excellent source of abstracts is the Combined Health Information Database. You will need to limit your search to book chapters and intraocular melanoma using the “Detailed Search” option. Go directly to the following hyperlink: http://chid.nih.gov/detail/detail.html. To find book chapters, use the drop boxes at the bottom of the search page where “You may refine your search by.” Select the dates and language you prefer, and the format option “Book Chapter.” By making these selections and typing in “intraocular melanoma” (or synonyms) into the “For these words:” box, you will only receive results on chapters in books.
General Home References In addition to references for intraocular melanoma, you may want a general home medical guide that spans all aspects of home healthcare. The following list is a recent sample of such guides (sorted alphabetically by title; hyperlinks provide rankings, information, and reviews at Amazon.com): · Cancer: 50 Essential Things to Do by Greg Anderson, O. Carl Simonton; Paperback - 184 pages; Revised & Updated edition (August 1999), Plume; ISBN: 0452280745; http://www.amazon.com/exec/obidos/ASIN/0452280745/icongroupinterna · Cancer Encyclopedia -- Collections of Anti-Cancer & Anti-Carcinogenic Agents, Chemicals, Drugs and Substances by John C. Bartone; Paperback (January 2002), ABBE Publishers Association of Washington, DC; ISBN:
found in the books available at NCBI. Click on hyperlinked results in the list of books in which the phrase is found. Currently, the majority of the links are between the books and PubMed. In the future, more links will be created between the books and other types of information, such as gene and protein sequences and macromolecular structures. See http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=Books.
Books 107
0788326791; http://www.amazon.com/exec/obidos/ASIN/0788326791/icongroupinterna · Cancer Sourcebook: Basic Consumer Health Information About Major Forms and Stages of Cancer by Edward J. Prucha (Editor); Library Binding - 1100 pages, 3rd edition (August 1, 2000), Omnigraphics, Inc.; ISBN: 0780802276; http://www.amazon.com/exec/obidos/ASIN/0780802276/icongroupinterna · Cancer Supportive Care: A Comprehensive Guide for Patients and Their Families by Ernest H. Rosenbaum, M.D., Isadora Rosenbaum, M.A.; Paperback - 472 pages (November 5, 1998), Somerville House Books Limited; ISBN: 1894042115; http://www.amazon.com/exec/obidos/ASIN/1894042115/icongroupinterna · Cancer Symptom Management: Patient Self-Care Guides (Book with CD-ROM for Windows & Macintosh) by Connie Henke Yarbro (Editor), et al; CD-ROM - 264 pages, 2nd Book & CD-Rom edition (January 15, 2000), Jones & Bartlett Publishing; ISBN: 0763711675; http://www.amazon.com/exec/obidos/ASIN/0763711675/icongroupint erna · Diagnosis Cancer: Your Guide Through the First Few Months by Wendy Schlessel Harpham, Ann Bliss Pilcher (Illustrator); Paperback: 230 pages; Revised & Updated edition (November 1997), .W. Norton & Company; ISBN: 0393316912; http://www.amazon.com/exec/obidos/ASIN/0393316912/icongroupinterna · The Human Side of Cancer: Living with Hope, Coping with Uncertainty by Jimmie C. Holland, M.D., Sheldon Lewis; Paperback - 368 pages (October 2, 2001), Quill; ISBN: 006093042X; http://www.amazon.com/exec/obidos/ASIN/006093042X/icongroupinterna
Vocabulary Builder CSF: Cerebrospinal fluid. The fluid flowing around the brain and spinal cord. CSF is produced in the ventricles of the brain. [NIH] Hormones: Chemicals produced by glands in the body and circulated in the bloodstream. Hormones control the actions of certain cells or organs. [NIH] Lenses: Pieces of glass or other transparent materials used for magnification or increased visual acuity. [NIH] Microscopy: The application of microscope magnification to the study of materials that cannot be properly seen by the unaided eye. [NIH]
Physician Guidelines and Databases 109
CHAPTER 6. PHYSICIAN GUIDELINES AND DATABASES Overview Doctors and medical researchers rely on a number of information sources to help patients with their conditions. Many will subscribe to journals or newsletters published by their professional associations or refer to specialized textbooks or clinical guides published for the medical profession. In this chapter, we focus on databases and Internet-based guidelines created or written for this professional audience.
NIH Guidelines For the more common diseases, The National Institutes of Health publish guidelines that are frequently consulted by physicians. Publications are typically written by one or more of the various NIH Institutes. For physician guidelines, commonly referred to as “clinical” or “professional” guidelines, you can visit the following Institutes: ·
Office of the Director (OD); guidelines consolidated across agencies available at http://www.nih.gov/health/consumer/conkey.htm
·
National Institute of General Medical Sciences (NIGMS); fact sheets available at http://www.nigms.nih.gov/news/facts/
·
National Library of Medicine (NLM); extensive encyclopedia (A.D.A.M., Inc.) with guidelines: http://www.nlm.nih.gov/medlineplus/healthtopics.html
·
National Cancer Institute (NCI); guidelines available at http://cancernet.nci.nih.gov/pdq/pdq_treatment.shtml
110 Intraocular Melanoma
In this chapter, we begin by reproducing one such guideline for intraocular melanoma:
What Is Intraocular Melanoma?29 Melanoma of the uveal tract (iris, ciliary body, and choroid) is the most common primary ocular cancer in adults. In patients with small, localized tumors, ocular melanoma is curable, and preservation of vision is possible with current treatment techniques. However, for patients with posterior uveal melanoma, whether the eye should be removed or more conservative treatment should be recommended is not known.30 A major clinical trial funded by the National Eye Institute, The Collaborative Ocular Melanoma Study, is ongoing.31 A number of factors influence prognosis. The most important are size, location, cell type, and extraocular extension (tumor size is the most critical factor). The selection of treatment depends on the site of origin (the choroid, ciliary body, or iris); size and location of the lesion; age of the patient; and whether extraocular invasion, recurrences, or metastases have occurred.32 These 3 events make the prognosis extremely poor, and long-term survival cannot be expected. In a group of patients with large posterior uveal melanomas, the concurrent presence of cytogenetic abnormalities was associated with a poor outcome.33 In general, the mortality rate is 46% after 15 years. Most investigators report approximately a 20% to 30% 5-year systemic disease recurrence rate following treatment. Unfortunately, for most patients, the best treatment option is not known, as appropriate controlled clinical trials have not been performed.34
The following guidelines appeared on the NCI website on Aug. 26, 2002. The text was last modified in February 2002. The text has been adapted for this sourcebook. 30 Straatsma BR, Fine SL, Earle JD, et al.: Enucleation versus plaque irradiation for choroidal melanoma. Ophthalmology 95(7): 1000-1004, 1988. 31 Fine SL, Collaborative Ocular Melanoma Study: Phase III Randomized Trial of Enucleation vs I-125 Plaque Radiotherapy in Patients with Medium-Size Choroidal Melanoma (Summary Last Modified 08/98), COMS-1, clinical trial, closed, 07/15/1998. 32 Gragoudas ES, Egan KM, Seddon JM, et al.: Survival of patients with metastases from uveal melanoma. Ophthalmology 98(3): 383-390, 1991. 33 White VA, Chambers JD, Courtright PD, et al.: Correlation of cytogenetic abnormalities with the outcome of patients with uveal melanoma. Cancer 83(2): 354-359, 1998. 34 Pach JM, Robertson DM: Metastasis from untreated uveal melanomas. Archives of Ophthalmology 104(11): 1624-1625, 1986. Gamel JW, McCurdy JB, McLean IW: A comparison of prognostic covariates for uveal melanoma. Investigative Ophthalmology and Visual Science 33(6): 1919-1922, 1992. 29
Physician Guidelines and Databases 111
Cellular Classification There is a correlation between cell type and prognosis in intraocular melanomas, especially of the choroid.35 Patients with tumors of the spindle cell variety have a better prognosis than those with tumors of the nonspindle variety.
Cell Type Spindle cell variety: ·
Spindle A type
·
Spindle B type
Nonspindle cell variety: ·
Epithelioid melanomas
·
Mixed cell type melanomas (usually spindle B and epithelioid cells)
·
Necrotic melanoma
Stage Information The uveal tract is divided into 3 regions: the iris, ciliary body, and choroid. Most uveal melanomas occur in the choroid. The ciliary body is less commonly the site of origin and the iris the least common. Melanomas of the iris, which are often of the spindle A variety, are relatively slow growing and relatively benign. The major routes of spread are local extension and by the blood stream. The uveal tract is a vascular structure without lymphatic channels. When regional lymph node involvement (preauricular, submandibular, and cervical nodes) is seen, subconjunctival extension of the primary tumor has occurred. Systemic metastases are generally hematogenous in origin, and the liver is the most common site. Lung and subcutaneous sites are common as well. In approximately two-thirds of the patients, the liver is the only site of detectable metastasis. In patients with a Jensen OA: Malignant melanomas of the human uvea: 25-year follow-up of cases in Denmark, 1943-1952. Acta Ophthalmologica 60(2): 161-182, 1982. Naumann GO: Uvea. In: Naumann GO, Apple DJ, Eds.: Pathology of the Eye. New York: Springer-Verlag, 1986, pp 459-468. Zimmerman LE: Malignant melanoma of the uveal tract. In: Spencer WH, Ed.: Ophthalmic Pathology: an Atlas and Textbook. Philadelphia: Saunders, Vol 3, 3rd ed., 1986, pp 20722139.
35
112 Intraocular Melanoma
history of ocular melanoma who present with hepatic metastases of unknown origin, metastatic melanoma should be considered in the differential diagnosis. New radiolabeled monoclonal antibody scans may facilitate detection of extraocular disease, however, these scans are not yet universally available.36 Classification by size: ·
Small: Small ocular melanomas are 2 mm to 3 mm or less in elevation*.
·
Medium: Medium-sized ocular melanomas range from 2 mm to 3 mm up to 10 mm in elevation and have a basal diameter of up to 16 mm.
·
Large: Large ocular melanomas have a diameter of more than 16 mm or are greater than 10 mm in elevation*.
*In clinical practice, the tumor base may be estimated in average optic disc diameters (dd) (1 dd = 1.5 mm). The average elevation may be estimated in diopters (3 diopters = 1 mm). Other techniques, such as ultrasonography, should be used to provide more accurate measurements. Iris (Anterior Uvea) The anterior uveal tract includes the iris. Iris melanomas are relatively benign, slow growing, and rarely metastasize.
Ciliary Body/Choroid (Posterior Uvea) The posterior uveal tract includes the ciliary body and choroid. The ciliary body is less commonly the site of origin than the choroid. Melanomas of the posterior uveal tract are cytologically more malignant, are detected later, and metastasize more frequently than iris melanomas.
Small Size Small intraocular melanomas are those that are 2 mm to 3 mm or less in elevation. There is general agreement that observation to document growth of small melanomas carries little risk. Bomanji J, Hungerford JL, Granowska M, et al.: Radioimmunoscintigraphy of ocular melanoma with 99mTc labelled cutaneous melanoma antibody fragments. British Journal of Ophthalmology 71(9): 651-658, 1987.
36
Physician Guidelines and Databases 113
Medium/Large Size Medium intraocular melanomas are those that are less than 16 mm in diameter and between 2 mm to 3 mm and 10 mm in elevation. The therapy of medium-sized intraocular melanomas remains the most controversial. Large intraocular melanomas are greater than 16 mm in diameter or greater than 10 mm in elevation and generally require irradiation or enucleation. Extraocular Extension Uveal melanomas may spread by local extension to involve the retina and vitreous or extend through the sclera into the orbit or into the optic nerve. Hematogenous metastasis most frequently involves the liver.
Treatment Option Overview The designations in PDQ that treatments are “standard” or “under clinical evaluation” are not to be used as a basis for reimbursement determinations. Iris Melanoma Iris malignant melanoma is the most common primary neoplasm of the iris and can be most easily seen by the physician on clinical examination. It is usually a small, discrete lesion, although it may occasionally be diffuse and infiltrative; multiple; and result in heterochromia, glaucoma, chronic uveitis, or spontaneous hyphema. Many patients are often aware of a pigmented spot on the iris that has been present for many years and only recently has begun to grow. With a slit lamp, gonioscopy, and serial slit lamp photography, the ophthalmologist can document the size and growth of the tumor without biopsy. Fluorescein angiography may be helpful in demonstrating the vascularity of the lesion, but is not diagnostic. Ultrasonography is of little value in the evaluation of iris melanoma. Iris melanoma is relatively benign with a 5-year survival rate of approximately 95%. This is related to the fact that iris melanomas are predominantly of the spindle A-cell type and are usually smaller in size than posterior melanoma because of earlier detection. Conservative management is generally advocated whenever possible, but surgical intervention may be
114 Intraocular Melanoma
justified with unequivocal tumor growth and with extensive melanomas at initial examination.37 Standard treatment options: ·
No treatment with careful observation including serial photography (in asymptomatic patients with stable lesions).
·
With documented growth, excisional surgery:
·
-
Iridectomy
-
Iridotrabeculectomy
-
Iridocyclectomy (if the ciliary body is involved)
Enucleation (in some patients with diffuse involvement of the iris, with involvement of more than one-half of the iris and anterior chamber angle and documented growth, with extensive iris involvement and intractable glaucoma, with large unresectable tumors and/or extraocular extension, and with tumors in eyes with no salvageable vision).
Ciliary Body and Choroid Melanoma, Small Size Melanomas of the choroid and ciliary body are usually diagnosed on clinical examination through the dilated pupil. Fundus photography is helpful in evaluating nevi and small malignant melanomas and in detecting the rate of choroidal tumor growth. Fluorescein angiography may show patterns helpful in differentiating melanomas from other lesions such as choroidal hemorrhage, hemangioma, and metastatic carcinoma. Ultrasonography shows characteristic patterns that may be diagnostic in differentiating melanomas from other masses. CT scanning is sometimes used to detect extraocular and optic nerve extension. Magnetic resonance imaging may prove to be of value.38 Tumors of the ciliary body and those close to the optic nervehead seem to have a poorer prognosis than other choroidal melanomas, but all of them have a poorer prognosis than iris melanomas because they are cytologically more malignant, detected later, and metastasize earlier. Char DH: Clinical Ocular Oncology. New York: Churchill Livingstone, 1989. Melanocytic tumors of the iris. In: Shields JA: Diagnosis and Management of Intraocular Tumors. Saint Louis: C.V. Mosby Company, 1983, pp 83-121. Geisse LJ, Robertson DM: Iris melanomas. American Journal of Ophthalmology 99(6): 638648, 1985. 38 Raymond WR, Char DH, Norman D, et al.: Magnetic resonance imaging evaluation of uveal tumors. American Journal of Ophthalmology 111(5): 633-641, 1991. 37
Physician Guidelines and Databases 115
Prognostic studies of patients with small choroidal melanomas have shown that many small lesions tend to be dormant and grow slowly with little or no metastatic potential. Furthermore, reports suggest that enucleation may occasionally result in and/or hasten metastases. This issue remains controversial. Careful and frequent observation is an option for patients in whom the diagnosis is uncertain or tumor growth is not documented. Observation is also prudent in asymptomatic patients with stable lesions, particularly elderly or seriously ill patients, and in patients with tumor growth in their only useful eye. No metastatic death has been observed in patients with a choroidal melanoma measuring less than 7 x 7 x 2 mm.39 Traditionally, enucleation has been the conventional treatment of melanoma of the choroid and ciliary body.40 However, radioactive ophthalmic applicators using cobalt-60 or iodine-125 have resulted in excellent shortterm survival. Long-term survival data are not yet available from large numbers of patients. Surgery and radiation techniques have made it possible to save the eye in some patients. External-beam irradiation using charged particles is used in a few centers.41 Proton-beam irradiation usually results in
Barr CC, Sipperley JO, Nicholson DH: Small melanomas of the choroid. Archives of Ophthalmology 96(9): 1580-1582, 1978. Char DH: The management of small choroidal melanomas. Survey of Ophthalmology 22(6): 377-386, 1978. Thomas JV, Green WR, Maumenee AE: Small choroidal melanomas: a long-term follow-up study. Archives of Ophthalmology 97(5): 861-864, 1979. 40 Shields JA: Counseling the patient with a posterior uveal melanoma. American Journal of Ophthalmology 106(1): 88-91, 1988. Straatsma BR, Fine SL, Earle JD, et al.: Enucleation versus plaque irradiation for choroidal melanoma. Ophthalmology 95(7): 1000-1004, 1988. 41 Packer S, Stoller S, Lesser ML, et al.: Long-term results of iodine 125 irradiation of uveal melanoma. Ophthalmology 99(5): 767-774, 1992. Shields JA, Augsburger JJ, Brady LW, et al.: Cobalt plaque therapy of posterior uveal melanomas. Ophthalmology 89(10):1201-1207, 1982. Lommatzsch PK: Beta-irradiation of choroidal melanoma with 106Ru/106Rh applicators: 16 years’ experience. Archives of Ophthalmology 101(5): 713-717, 1983. Seddon JM, Gragoudas ES, Polivagianis L, et al.: Visual outcome after proton beam irradiation of uveal melanoma. Ophthalmology 93(5): 666-674, 1986. Gragoudas ES, Seddon JM, Egan KM, et al.: Metastasis from uveal melanoma after proton beam irradiation. Ophthalmology 95(7): 992-999, 1988. Char DH, Castro JR, Kroll SM, et al.: Five-year follow-up of helium ion therapy for uveal melanoma. Archives of Ophthalmology 108(2): 209-214, 1990. The management of posterior uveal melanomas. In: Shields JA: Diagnosis and Management of Intraocular Tumors. Saint Louis: C.V. Mosby Company, 1983, pp 210-254. 39
116 Intraocular Melanoma
radiation maculopathy but ambulatory vision is preserved in the majority of patients.42 The management of posterior uveal melanoma is controversial. A major clinical trial funded by the National Eye Institute, The Collaborative Ocular Melanoma Study (COMS), is ongoing.43 Because there is no agreement concerning the management of small posterior uveal melanomas, investigators in the COMS will select a treatment, which is often observation, after discussion with the patient. Prospective and randomized clinical trials are ongoing for patients with medium and large tumors. Standard treatment options: ·
Careful and frequent observation.44
·
Local irradiation with: -
Cobalt-60 or iodine-125 plaques.
-
Beta irradiation
-
106 RU/106 Rh.45
-
Proton beam (specialized equipment at Massachusetts General Hospital)46
Guyer DR, Mukai S, Egan KM, et al.: Radiation maculopathy after proton beam irradiation for choroidal melanoma. Ophthalmology 99(8): 1278-1285, 1992. 43 Fine SL, Collaborative Ocular Melanoma Study: Phase III Randomized Trial of Enucleation vs I-125 Plaque Radiotherapy in Patients with Medium-Size Choroidal Melanoma (Summary Last Modified 08/98), COMS-1, clinical trial, closed, 07/15/1998. 44 Barr CC, Sipperley JO, Nicholson DH: Small melanomas of the choroid. Archives of Ophthalmology 96(9): 1580-1582, 1978. Char DH: The management of small choroidal melanomas. Survey of Ophthalmology 22(6): 377-386, 1978. Thomas JV, Green WR, Maumenee AE: Small choroidal melanomas: a long-term follow-up study. Archives of Ophthalmology 97(5): 861-864, 1979. 45 Packer S, Stoller S, Lesser ML, et al.: Long-term results of iodine 125 irradiation of uveal melanoma. Ophthalmology 99(5): 767-774, 1992. Shields JA, Augsburger JJ, Brady LW, et al.: Cobalt plaque therapy of posterior uveal melanomas. Ophthalmology 89(10):1201-1207, 1982. Lommatzsch PK: Beta-irradiation of choroidal melanoma with 106Ru/106Rh applicators: 16 years’ experience. Archives of Ophthalmology 101(5): 713-717, 1983. Davidorf FH, Pajka JT, Makley TA, et al.: Radiotherapy for choroidal melanoma: an 18-year experience with radon. Archives of Ophthalmology 105(3): 352-355, 1987. 46 Seddon JM, Gragoudas ES, Polivagianis L, et al.: Visual outcome after proton beam irradiation of uveal melanoma. Ophthalmology 93(5): 666-674, 1986. Gragoudas ES, Seddon JM, Egan KM, et al.: Metastasis from uveal melanoma after proton beam irradiation. Ophthalmology 95(7): 992-999, 1988. 42
Physician Guidelines and Databases 117
-
Helium ions Laboratories)47
(specialized
equipment
at
Lawrence
·
Enucleation.48
·
Enucleation with preoperative external-beam irradiation.49
Berkley
Ciliary Body and Choroid Melanoma, Medium/Large Size Melanomas of the choroid and ciliary body are generally diagnosed on clinical examination through the dilated pupil. Fundus photography is of value in evaluating nevi and small malignant melanomas and in detecting the rate of choroidal tumor growth. Fluorescein angiography may show angiographic patterns helpful in differentiating melanomas from other lesions such as choroidal hemorrhage or hemangioma. Ultrasonography shows characteristic patterns that may be diagnostic in differentiating melanomas from other masses. CT scanning is sometimes used to detect extraocular and optic nerve extension. Magnetic resonance imaging may prove to be of value. Cobalt-60, iodine-125, and other ophthalmic plaques can be effective in treatment of medium-size melanomas. The role of enucleation in the management of posterior choroidal melanomas is controversial, but enucleation remains the standard therapy for most large choroidal melanomas and melanomas causing severe glaucoma or invading the optic nerve. However, reports have shown that enucleation may not result in improved survival and may actually result in tumor metastases. Use of the “no touch” surgical technique had been proposed to minimize the risk of tumor cell embolization during enucleation. No-touch enucleation has been abandoned by many clinicians, as it has never been proven superior to a skilled and gentle enucleation procedure. Preoperative or postoperative irradiation is a promising approach under evaluation that also could decrease the chances of precipitating metastases; however, a single study
Guyer DR, Mukai S, Egan KM, et al.: Radiation maculopathy after proton beam irradiation for choroidal melanoma. Ophthalmology 99(8): 1278-1285, 1992. 47 Char DH, Castro JR, Kroll SM, et al.: Five-year follow-up of helium ion therapy for uveal melanoma. Archives of Ophthalmology 108(2): 209-214, 1990. 48 The management of posterior uveal melanomas. In: Shields JA: Diagnosis and Management of Intraocular Tumors. Saint Louis: C.V. Mosby Company, 1983, pp 210-254. Kersten RC: Management of choroidal malignant melanoma at Iowa. Ophthalmologica 189(1-2): 24-35, 1984. 49 Fine SL, Straatsma BR, Earle JD, et al.: Failure of preenucleation radiation to decrease uveal melanoma mortality: the Collaborative Ocular Melanoma Study Steering Committee. American Journal of Ophthalmology 107(4): 440-442, 1989.
118 Intraocular Melanoma
showed no benefit.50 Advances in radiation techniques have made it possible to save the eye in selected patients with melanomas that are considered medium to large in size. Long-term results are not available, and long-term evaluations and analyses show similar survival rates to enucleation.51 In certain centers, charged particle therapy has been applied to choroidal melanomas. This treatment requires special equipment. The results have been encouraging.52 Proton-beam irradiation usually results in radiation maculopathy but ambulatory vision is preserved in the majority of patients.53 In some centers, small- and medium-sized tumors have been successfully excised. These operations require special techniques and instrumentation, and should be performed by specially trained surgeons.54 Because the best treatment of patients with medium and large choroidal melanomas is not known, a major clinical trial funded by the National Eye
Fine SL, Straatsma BR, Earle JD, et al.: Failure of preenucleation radiation to decrease uveal melanoma mortality: the Collaborative Ocular Melanoma Study Steering Committee. American Journal of Ophthalmology 107(4): 440-442, 1989. 51 Augsburger JJ, Gamel JW, Lauritzen K, et al.: Cobalt-60 plaque radiotherapy vs enucleation for posterior uveal melanoma. American Journal of Ophthalmology 109(5): 585592, 1990. Gass JD: Comparison of prognosis after enucleation versus cobalt-60 irradiation of melanomas. Archives of Ophthalmology 103(7): 916-923, 1985. Manschot WA, Van Strik R: Is irradiation a justifiable treatment of choroidal melanoma? Analysis of published results. British Journal of Ophthalmology 71(5): 348-352, 1987. Kindy-Degnan NA, Char DH, Castro JR, et al.: Effect of various doses of radiation for uveal melanoma on regression, visual acuity, complications, and survival. American Journal of Ophthalmology 107(2): 114-120, 1989. Karlsson UL, Augsburger JJ, Shields JA, et al.: Recurrence of posterior uveal melanoma after 60Co episcleral plaque therapy. Ophthalmology 96(3): 382-388, 1989. Shields CL, Shields JA, Karlsson UL, et al.: Reasons for enucleation after plaque radiotherapy for posterior uveal melanoma: clinical findings. Ophthalmology 96(6): 919923, 1989. 52 Gragoudas ES, Seddon JM, Egan K, et al.: Long-term results of proton beam irradiated uveal melanomas. Ophthalmology 94(4): 349-353, 1987. Seddon JM, Gragoudas ES, Egan KM, et al.: Relative survival rates after alternative therapies for uveal melanoma. Ophthalmology 97(6): 769-777, 1990. Egan KM, Gragoudas ES, Seddon JM, et al.: The risk of enucleation after proton beam irradiation of uveal melanoma. Ophthalmology 96(9): 1377-1383, 1989. 53 Guyer DR, Mukai S, Egan KM, et al.: Radiation maculopathy after proton beam irradiation for choroidal melanoma. Ophthalmology 99(8): 1278-1285, 1992. 54 Foulds WS: Management of intraocular melanoma. British Journal of Ophthalmology 74(9): 559-560, 1990. Peyman GA, Juarez CP, Diamond JG, et al.: Ten years experience with eye wall resection for uveal malignant melanoma. Ophthalmology 91(12): 1720-1725, 1984. 50
Physician Guidelines and Databases 119
Institute, The Collaborative Ocular Melanoma Study (COMS), is ongoing.55 The COMS investigators think that the study offers the best current treatment approach for eligible patients. Patients with medium-sized tumors were randomized to receive either radioactive I-125 plaque treatment or enucleation. Patients with large tumors were randomized to receive enucleation with or without preoperative external-beam radiation. Recruitment for this portion of the trial was completed in 7/95. No results of the trial have been announced. Standard treatment options: ·
Careful and frequent observation is an option for patients in whom the diagnosis is uncertain or tumor growth is not documented. It is also prudent in asymptomatic patients with stable lesions, in the elderly, in the seriously ill, and perhaps in patients with tumor growth in their only useful eye.
·
Local irradiation with:
·
-
Cobalt-60 or iodine-125 plaques.
-
Beta irradiation
-
106 RU/106 Rh.56
-
Proton beam (specialized equipment at Massachusetts General Hospital)57
-
Helium ions Laboratories)58
(specialized
equipment
at
Lawrence
Berkeley
Enucleation.59
Fine SL, Collaborative Ocular Melanoma Study: Phase III Randomized Trial of Enucleation vs I-125 Plaque Radiotherapy in Patients with Medium-Size Choroidal Melanoma (Summary Last Modified 08/98), COMS-1, clinical trial, closed, 07/15/1998. 56 Packer S, Stoller S, Lesser ML, et al.: Long-term results of iodine 125 irradiation of uveal melanoma. Ophthalmology 99(5): 767-774, 1992. Shields JA, Augsburger JJ, Brady LW, et al.: Cobalt plaque therapy of posterior uveal melanomas. Ophthalmology 89(10):1201-1207, 1982. Lommatzsch PK: Beta-irradiation of choroidal melanoma with 106Ru/106Rh applicators: 16 years’ experience. Archives of Ophthalmology 101(5): 713-717, 1983. 57 Gragoudas ES, Seddon JM, Egan K, et al.: Long-term results of proton beam irradiated uveal melanomas. Ophthalmology 94(4): 349-353, 1987. Seddon JM, Gragoudas ES, Egan KM, et al.: Relative survival rates after alternative therapies for uveal melanoma. Ophthalmology 97(6): 769-777, 1990. Guyer DR, Mukai S, Egan KM, et al.: Radiation maculopathy after proton beam irradiation for choroidal melanoma. Ophthalmology 99(8): 1278-1285, 1992. 58 Linstadt D, Castro J, Char D, et al.: Long-term results of helium ion irradiation of uveal melanoma. International Journal of Radiation Oncology, Biology, Physics 19(3): 613-618, 1990. 55
120 Intraocular Melanoma
·
Enucleation with preoperative external-beam irradiation.
Treatment options under clinical evaluation: ·
The management of medium and large choroidal melanomas is controversial. Some investigators suggest that survival following radiation therapy is comparable to survival following enucleation. However, there are prominent ophthalmologists who disagree. The Collaborative Ocular Melanoma Study (COMS) is a multicenter, randomized, controlled clinical trial which will compare survival of patients with medium and large choroidal melanomas with 1 of 2 management strategies. The COMS is supported by the National Eye Institute, and there are 42 clinical centers in North America.60 Such clinical treatment trials are now justified because the misdiagnosis rate of choroid melanomas has been decreased to less than 0.5% and in the first report of the collaborative study, only 5 out of over 1,000 cases were misdiagnosed.61
Extraocular Extension Melanoma Extrascleral extension usually confers a poor prognosis. For patients with gross tumor involvement of the orbit, treatment requires orbital exenteration often combined with pre- or postoperative radiation therapy. However, there is no evidence that this radical surgery will prolong life. Most patients with localized or encapsulated extraocular extension are not exenterated. This subject is controversial.62 The management of posterior uveal melanomas. In: Shields JA: Diagnosis and Management of Intraocular Tumors. Saint Louis: C.V. Mosby Company, 1983, pp 210-254. Kersten RC: Management of choroidal malignant melanoma at Iowa. Ophthalmologica 189(1-2): 24-35, 1984. 60 Straatsma BR, Fine SL, Earle JD, et al.: Enucleation versus plaque irradiation for choroidal melanoma. Ophthalmology 95(7): 1000-1004, 1988. Shields JA: Counseling the patient with a posterior uveal melanoma. American Journal of Ophthalmology 106(1): 88-91, 1988. 61 Collaborative Ocular Melanoma Study: Accuracy of diagnosis of choroidal melanomas in the Collaborative Ocular Melanoma Study: COMS report No. 1. Archives of Ophthalmology 108(9): 1268-1273, 1990. 62 Shammas HF, Blodi FC: Prognostic factors in choroidal and ciliary body melanomas. Archives of Ophthalmology 95(1): 63-69, 1977. Pach JM, Robertson DM, Taney BS, et al.: Prognostic factors in choroidal and ciliary body melanomas with extrascleral extension. American Journal of Ophthalmology 101(3): 325331, 1986. Kersten RC, Tse DT, Anderson RL, et al.: The role of orbital exenteration in choroidal melanomas with extrascleral extension. Ophthalmology 92(3): 436-443, 1985. 59
Physician Guidelines and Databases 121
Recurrent Intraocular Melanoma The prognosis for any patient with recurring or relapsing disease is poor, regardless of cell type or stage. The question and selection of further treatment depends on many factors, including the extent of the lesion, age and health of the patient, prior treatment, and site of recurrence, as well as individual patient considerations. Clinical trials are appropriate and should be considered whenever possible.
NIH Databases In addition to the various Institutes of Health that publish professional guidelines, the NIH has designed a number of databases for professionals.63 Physician-oriented resources provide a wide variety of information related to the biomedical and health sciences, both past and present. The format of these resources varies. Searchable databases, bibliographic citations, full text articles (when available), archival collections, and images are all available. The following are referenced by the National Library of Medicine:64 ·
Bioethics: Access to published literature on the ethical, legal and public policy issues surrounding healthcare and biomedical research. This information is provided in conjunction with the Kennedy Institute of Ethics located at Georgetown University, Washington, D.C.: http://www.nlm.nih.gov/databases/databases_bioethics.html
·
HIV/AIDS Resources: Describes various links and databases dedicated to HIV/AIDS research: http://www.nlm.nih.gov/pubs/factsheets/aidsinfs.html
·
NLM Online Exhibitions: Describes “Exhibitions in the History of Medicine”: http://www.nlm.nih.gov/exhibition/exhibition.html. Additional resources for historical scholarship in medicine: http://www.nlm.nih.gov/hmd/hmd.html
·
Biotechnology Information: Access to public databases. The National Center for Biotechnology Information conducts research in computational biology, develops software tools for analyzing genome data, and disseminates biomedical information for the better
Hykin PG, McCartney AC, Plowman PN, et al.: Postenucleation orbital radiotherapy for the treatment of malignant melanoma of the choroid with extrascleral extension. British Journal of Ophthalmology 74(1): 36-39, 1990. 63 Remember, for the general public, the National Library of Medicine recommends the databases referenced in MEDLINEplus (http://medlineplus.gov/ or http://www.nlm.nih.gov/medlineplus/databases.html). 64 See http://www.nlm.nih.gov/databases/databases.html.
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understanding of molecular processes affecting human health and disease: http://www.ncbi.nlm.nih.gov/ ·
Population Information: The National Library of Medicine provides access to worldwide coverage of population, family planning, and related health issues, including family planning technology and programs, fertility, and population law and policy: http://www.nlm.nih.gov/databases/databases_population.html
·
Cancer Information: Access to caner-oriented databases: http://www.nlm.nih.gov/databases/databases_cancer.html
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Profiles in Science: Offering the archival collections of prominent twentieth-century biomedical scientists to the public through modern digital technology: http://www.profiles.nlm.nih.gov/
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Chemical Information: Provides links to various chemical databases and references: http://sis.nlm.nih.gov/Chem/ChemMain.html
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Clinical Alerts: Reports the release of findings from the NIH-funded clinical trials where such release could significantly affect morbidity and mortality: http://www.nlm.nih.gov/databases/alerts/clinical_alerts.html
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Space Life Sciences: Provides links and information to space-based research (including NASA): http://www.nlm.nih.gov/databases/databases_space.html
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MEDLINE: Bibliographic database covering the fields of medicine, nursing, dentistry, veterinary medicine, the healthcare system, and the pre-clinical sciences: http://www.nlm.nih.gov/databases/databases_medline.html
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Toxicology and Environmental Health Information (TOXNET): Databases covering toxicology and environmental health: http://sis.nlm.nih.gov/Tox/ToxMain.html
·
Visible Human Interface: Anatomically detailed, three-dimensional representations of normal male and female human bodies: http://www.nlm.nih.gov/research/visible/visible_human.html
While all of the above references may be of interest to physicians who study and treat intraocular melanoma, the following are particularly noteworthy.
The Combined Health Information Database A comprehensive source of information on clinical guidelines written for professionals is the Combined Health Information Database. You will need
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to limit your search to “Brochure/Pamphlet,” “Fact Sheet,” or “Information Package” and intraocular melanoma using the “Detailed Search” option. Go directly to the following hyperlink: http://chid.nih.gov/detail/detail.html. To find associations, use the drop boxes at the bottom of the search page where “You may refine your search by.” For the publication date, select “All Years,” select your preferred language, and the format option “Fact Sheet.” By making these selections and typing “intraocular melanoma” (or synonyms) into the “For these words:” box above, you will only receive results on fact sheets dealing with intraocular melanoma.
The NLM Gateway65 The NLM (National Library of Medicine) Gateway is a Web-based system that lets users search simultaneously in multiple retrieval systems at the U.S. National Library of Medicine (NLM). It allows users of NLM services to initiate searches from one Web interface, providing “one-stop searching” for many of NLM’s information resources or databases.66 One target audience for the Gateway is the Internet user who is new to NLM’s online resources and does not know what information is available or how best to search for it. This audience may include physicians and other healthcare providers, researchers, librarians, students, and, increasingly, patients, their families, and the public.67 To use the NLM Gateway, simply go to the search site at http://gateway.nlm.nih.gov/gw/Cmd. Type “intraocular melanoma” (or synonyms) into the search box and click “Search.” The results will be presented in a tabular form, indicating the number of references in each database category.
Adapted from NLM: http://gateway.nlm.nih.gov/gw/Cmd?Overview.x. The NLM Gateway is currently being developed by the Lister Hill National Center for Biomedical Communications (LHNCBC) at the National Library of Medicine (NLM) of the National Institutes of Health (NIH). 67 Other users may find the Gateway useful for an overall search of NLM’s information resources. Some searchers may locate what they need immediately, while others will utilize the Gateway as an adjunct tool to other NLM search services such as PubMed® and MEDLINEplus®. The Gateway connects users with multiple NLM retrieval systems while also providing a search interface for its own collections. These collections include various types of information that do not logically belong in PubMed, LOCATORplus, or other established NLM retrieval systems (e.g., meeting announcements and pre-1966 journal citations). The Gateway will provide access to the information found in an increasing number of NLM retrieval systems in several phases. 65 66
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Results Summary Category Items Found Journal Articles 350750 Books / Periodicals / Audio Visual 2586 Consumer Health 294 Meeting Abstracts 2575 Other Collections 87 Total 356292
HSTAT68 HSTAT is a free, Web-based resource that provides access to full-text documents used in healthcare decision-making.69 HSTAT’s audience includes healthcare providers, health service researchers, policy makers, insurance companies, consumers, and the information professionals who serve these groups. HSTAT provides access to a wide variety of publications, including clinical practice guidelines, quick-reference guides for clinicians, consumer health brochures, evidence reports and technology assessments from the Agency for Healthcare Research and Quality (AHRQ), as well as AHRQ’s Put Prevention Into Practice.70 Simply search by “intraocular melanoma” (or synonyms) at the following Web site: http://text.nlm.nih.gov. Coffee Break: Tutorials for Biologists71 Some patients may wish to have access to a general healthcare site that takes a scientific view of the news and covers recent breakthroughs in biology that may one day assist physicians in developing treatments. To this end, we Adapted from HSTAT: http://www.nlm.nih.gov/pubs/factsheets/hstat.html. The HSTAT URL is http://hstat.nlm.nih.gov/. 70 Other important documents in HSTAT include: the National Institutes of Health (NIH) Consensus Conference Reports and Technology Assessment Reports; the HIV/AIDS Treatment Information Service (ATIS) resource documents; the Substance Abuse and Mental Health Services Administration’s Center for Substance Abuse Treatment (SAMHSA/CSAT) Treatment Improvement Protocols (TIP) and Center for Substance Abuse Prevention (SAMHSA/CSAP) Prevention Enhancement Protocols System (PEPS); the Public Health Service (PHS) Preventive Services Task Force’s Guide to Clinical Preventive Services; the independent, nonfederal Task Force on Community Services Guide to Community Preventive Services; and the Health Technology Advisory Committee (HTAC) of the Minnesota Health Care Commission (MHCC) health technology evaluations. 71 Adapted from http://www.ncbi.nlm.nih.gov/Coffeebreak/Archive/FAQ.html. 68 69
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recommend “Coffee Break,” a collection of short reports on recent biological discoveries. Each report incorporates interactive tutorials that demonstrate how bioinformatics tools are used as a part of the research process. Currently, all Coffee Breaks are written by NCBI staff.72 Each report is about 400 words and is usually based on a discovery reported in one or more articles from recently published, peer-reviewed literature.73 This site has new articles every few weeks, so it can be considered an online magazine of sorts, and intended for general background information. You can access the Coffee Break Web site at the following hyperlink: http://www.ncbi.nlm.nih.gov/Coffeebreak/.
Other Commercial Databases In addition to resources maintained by official agencies, other databases exist that are commercial ventures addressing medical professionals. Here are a few examples that may interest you: ·
CliniWeb International: Index and table of contents to selected clinical information on the Internet; see http://www.ohsu.edu/cliniweb/.
·
Image Engine: Multimedia electronic medical record system that integrates a wide range of digitized clinical images with textual data stored in the University of Pittsburgh Medical Center’s MARS electronic medical record system; see the following Web site: http://www.cml.upmc.edu/cml/imageengine/imageEngine.html.
·
Medical World Search: Searches full text from thousands of selected medical sites on the Internet; see http://www.mwsearch.com/.
·
MedWeaver: Prototype system that allows users to search differential diagnoses for any list of signs and symptoms, to search medical literature, and to explore relevant Web sites; see http://www.med.virginia.edu/~wmd4n/medweaver.html.
·
Metaphrase: Middleware component intended for use by both caregivers and medical records personnel. It converts the informal language generally used by caregivers into terms from formal, controlled
The figure that accompanies each article is frequently supplied by an expert external to NCBI, in which case the source of the figure is cited. The result is an interactive tutorial that tells a biological story. 73 After a brief introduction that sets the work described into a broader context, the report focuses on how a molecular understanding can provide explanations of observed biology and lead to therapies for diseases. Each vignette is accompanied by a figure and hypertext links that lead to a series of pages that interactively show how NCBI tools and resources are used in the research process. 72
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vocabularies; see the following http://www.lexical.com/Metaphrase.html.
Web
site:
The Genome Project and Intraocular Melanoma With all the discussion in the press about the Human Genome Project, it is only natural that physicians, researchers, and patients want to know about how human genes relate to intraocular melanoma. In the following section, we will discuss databases and references used by physicians and scientists who work in this area.
Online Mendelian Inheritance in Man (OMIM) The Online Mendelian Inheritance in Man (OMIM) database is a catalog of human genes and genetic disorders authored and edited by Dr. Victor A. McKusick and his colleagues at Johns Hopkins and elsewhere. OMIM was developed for the World Wide Web by the National Center for Biotechnology Information (NCBI).74 The database contains textual information, pictures, and reference information. It also contains copious links to NCBI’s Entrez database of MEDLINE articles and sequence information. Go to http://www.ncbi.nlm.nih.gov/Omim/searchomim.html to search the database. Type “intraocular melanoma” (or synonyms) in the search box, and click “Submit Search.” If too many results appear, you can narrow the search by adding the word “clinical.” Each report will have additional links to related research and databases. By following these links, especially the link titled “Database Links,” you will be exposed to numerous specialized databases that are largely used by the scientific community. These databases are overly technical and seldom used by the general public, but offer an abundance of information. The following is an example of the results you can obtain from the OMIM for intraocular melanoma: ·
Homocystinuria Web site: http://www.ncbi.nlm.nih.gov/htbinpost/Omim/dispmim?236200
Adapted from http://www.ncbi.nlm.nih.gov/. Established in 1988 as a national resource for molecular biology information, NCBI creates public databases, conducts research in computational biology, develops software tools for analyzing genome data, and disseminates biomedical information--all for the better understanding of molecular processes affecting human health and disease.
74
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·
Interferon, Alpha-2 Web site: http://www.ncbi.nlm.nih.gov/htbinpost/Omim/dispmim?147562
·
Melanoma, Cutaneous Malignant Web site: http://www.ncbi.nlm.nih.gov/htbinpost/Omim/dispmim?155600
·
Melanoma, Malignant Familial Intraocular Web site: http://www.ncbi.nlm.nih.gov/htbinpost/Omim/dispmim?155700
·
Melanoma, Uveal Web site: http://www.ncbi.nlm.nih.gov/htbinpost/Omim/dispmim?155720
·
Melanoma, Uveal, Susceptibility To, 1 Web site: http://www.ncbi.nlm.nih.gov/htbinpost/Omim/dispmim?606660
·
Melanoma, Uveal, Susceptibility To, 2 Web site: http://www.ncbi.nlm.nih.gov/htbinpost/Omim/dispmim?606661
·
Vascular Endothelial Growth Factor Web site: http://www.ncbi.nlm.nih.gov/htbinpost/Omim/dispmim?192240
Genes and Disease (NCBI - Map) The Genes and Disease database is produced by the National Center for Biotechnology Information of the National Library of Medicine at the National Institutes of Health. This Web site categorizes each disorder by the system of the body associated with it. Go to http://www.ncbi.nlm.nih.gov/disease/, and browse the system pages to have a full view of important conditions linked to human genes. Since this site is regularly updated, you may wish to re-visit it from time to time. The following systems and associated disorders are addressed: ·
Cancer: Uncontrolled cell division. Examples: Breast And Ovarian Cancer, Burkitt lymphoma, chronic myeloid leukemia, colon cancer, lung cancer, malignant melanoma, multiple endocrine neoplasia, neurofibromatosis, p53 tumor suppressor, pancreatic cancer, prostate cancer, Ras oncogene, RB: retinoblastoma, von Hippel-Lindau syndrome. Web site: http://www.ncbi.nlm.nih.gov/disease/Cancer.html
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Entrez Entrez is a search and retrieval system that integrates several linked databases at the National Center for Biotechnology Information (NCBI). These databases include nucleotide sequences, protein sequences, macromolecular structures, whole genomes, and MEDLINE through PubMed. Entrez provides access to the following databases: ·
PubMed: Biomedical literature (PubMed), Web site: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed
·
Nucleotide Sequence Database (Genbank): Web site: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=Nucleotide
·
Protein Sequence Database: Web site: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=Protein
·
Structure: Three-dimensional macromolecular structures, Web site: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=Structure
·
Genome: Complete genome assemblies, Web site: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=Genome
·
PopSet: Population study data sets, Web site: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=Popset
·
OMIM: Online Mendelian Inheritance in Man, Web site: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=OMIM
·
Taxonomy: Organisms in GenBank, Web site: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=Taxonomy
·
Books: Online books, Web site: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=books
·
ProbeSet: Gene Expression Omnibus (GEO), Web site: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=geo
·
3D Domains: Domains from Entrez Structure, Web site: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=geo
·
NCBI’s Protein Sequence Information Survey Results: Web site: http://www.ncbi.nlm.nih.gov/About/proteinsurvey/
To access the Entrez system at the National Center for Biotechnology Information, go to http://www.ncbi.nlm.nih.gov/entrez, and then select the database that you would like to search. The databases available are listed in
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the drop box next to “Search.” In the box next to “for,” enter “intraocular melanoma” (or synonyms) and click “Go.”
Jablonski’s Multiple Congenital Anomaly/Mental Retardation (MCA/MR) Syndromes Database75 This online resource can be quite useful. It has been developed to facilitate the identification and differentiation of syndromic entities. Special attention is given to the type of information that is usually limited or completely omitted in existing reference sources due to space limitations of the printed form. At the following Web site you can also search across syndromes using an index: http://www.nlm.nih.gov/mesh/jablonski/syndrome_toc/toc_a.html. You can search by keywords at this Web site: http://www.nlm.nih.gov/mesh/jablonski/syndrome_db.html. The Genome Database76 Established at Johns Hopkins University in Baltimore, Maryland in 1990, the Genome Database (GDB) is the official central repository for genomic mapping data resulting from the Human Genome Initiative. In the spring of 1999, the Bioinformatics Supercomputing Centre (BiSC) at the Hospital for Sick Children in Toronto, Ontario assumed the management of GDB. The Human Genome Initiative is a worldwide research effort focusing on structural analysis of human DNA to determine the location and sequence of the estimated 100,000 human genes. In support of this project, GDB stores and curates data generated by researchers worldwide who are engaged in the mapping effort of the Human Genome Project (HGP). GDB’s mission is to provide scientists with an encyclopedia of the human genome which is continually revised and updated to reflect the current state of scientific knowledge. Although GDB has historically focused on gene mapping, its focus will broaden as the Genome Project moves from mapping to sequence, and finally, to functional analysis. To access the GDB, simply go to the following hyperlink: http://www.gdb.org/. Search “All Biological Data” by “Keyword.” Type Adapted from the National Library of Medicine: http://www.nlm.nih.gov/mesh/jablonski/about_syndrome.html. 76 Adapted from the Genome Database: http://gdbwww.gdb.org/gdb/aboutGDB.html#mission. 75
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“intraocular melanoma” (or synonyms) into the search box, and review the results. If more than one word is used in the search box, then separate each one with the word “and” or “or” (using “or” might be useful when using synonyms). This database is extremely technical as it was created for specialists. The articles are the results which are the most accessible to nonprofessionals and often listed under the heading “Citations.” The contact names are also accessible to non-professionals.
Specialized References The following books are specialized references written for professionals interested in intraocular melanoma (sorted alphabetically by title, hyperlinks provide rankings, information, and reviews at Amazon.com): · Advanced and Critical Care Oncology Nursing: Managing Primary Complications by Cynthia C. Chernecky (Editor), et al; Paperback - 736 pages (September 18, 1997), W B Saunders Co; ISBN: 0721668607; http://www.amazon.com/exec/obidos/ASIN/0721668607/icongroupinterna · Cancer: Etiology, Diagnosis, and Treatment by Walter J. Burdette; Paperback - 287 pages, 1st edition (January 15, 1998), McGraw Hill Text; ISBN: 0070089922; http://www.amazon.com/exec/obidos/ASIN/0070089922/icongroupinterna · Cancer Management: A Multidisciplinary Approach: Medical, Surgical & Radiation by Richard Pazdur (Editor), et al; Paperback - 982 pages, 5th edition (June 15, 2001), Publisher Research & Representation, Inc.; ISBN: 1891483080; http://www.amazon.com/exec/obidos/ASIN/1891483080/icongroupinterna · Familial Cancer and Prevention: Molecular Epidemiology: A New Strategy Toward Cancer Control by Joji Utsunomiya (Editor), et al; Hardcover (April 1999), Wiley-Liss; ISBN: 0471249378; http://www.amazon.com/exec/obidos/ASIN/0471249378/icongroupinterna · Fundamentals of Cancer Epidemiology by Philip C. Nasca, Ph.D. (Editor), Pastides Harris, Ph.D., MPH (Editor); Hardcover - 368 pages, 1st edition (February 15, 2001), Aspen Publishers, Inc.; ISBN: 0834217767; http://www.amazon.com/exec/obidos/ASIN/0834217767/icongroupinterna · Helping Cancer Patients Cope: A Problem-Solving Approach by Arthur M. Nezu (Editor), et al; Hardcover - 314 pages (December 15, 1998), American Psychological Association (APA); ISBN: 1557985332; http://www.amazon.com/exec/obidos/ASIN/1557985332/icongroupinterna
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· Quantitative Estimation and Prediction of Human Cancer Risks (Iarc Scientific Publications, 131) by Suresh H. Moolgavkar (Editor), et al; Paperback (September 1999), Oxford University Press; ISBN: 9283221311; http://www.amazon.com/exec/obidos/ASIN/9283221311/icongroupinterna · Textbook of Cancer Epidemiology by ADAMI, et al; Hardcover - 385 pages, 1st edition (July 15, 2002), Oxford University Press; ISBN: 0195109694; http://www.amazon.com/exec/obidos/ASIN/0195109694/icongroupint erna
Vocabulary Builder Angiography: A procedure to x-ray blood vessels. The blood vessels can be seen because of an injection of a dye that shows up in the x-ray pictures. [NIH] Asymptomatic: Having no signs or symptoms of disease. [NIH] Benign: Not cancerous; does not invade nearby tissue or spread to other parts of the body. [NIH] Chronic: A disease or condition that persists or progresses over a long period of time. [NIH] Cobalt: A trace element that is a component of vitamin B12. It has the atomic symbol Co, atomic number 27, and atomic weight 58.93. It is used in nuclear weapons, alloys, and pigments. Deficiency in animals leads to anemia; its excess in humans can lead to erythrocytosis. [NIH] Embolization: The blocking of an artery by a clot or foreign material. Embolization can be done as treatment to block the flow of blood to a tumor. [NIH]
Encapsulated: Confined to a specific, localized area and surrounded by a thin layer of tissue. [NIH] Fundus: The larger part of a hollow organ that is farthest away from the organ's opening. The bladder, gallbladder, stomach, uterus, eye, and cavity of the middle ear all have a fundus. [NIH] Gonioscopy: Examination of the angle of the anterior chamber of the eye with the gonioscope. [EU] Hemorrhage: Bleeding or escape of blood from a vessel. [NIH] Iodine: A nonmetallic element of the halogen group that is represented by the atomic symbol I, atomic number 53, and atomic weight of 126.90. It is a nutritionally essential element, especially important in thyroid hormone synthesis. In solution, it has anti-infective properties and is used topically. [NIH]
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Metastasize: To spread from one part of the body to another. When cancer cells metastasize and form secondary tumors, the cells in the metastatic tumor are like those in the original (primary) tumor. [NIH] Molecular: Of, pertaining to, or composed of molecules : a very small mass of matter. [EU] Pupil: The aperture in the iris through which light passes. [NIH] Radiolabeled: Any compound that has been joined with a radioactive substance. [NIH] Recurrence: The return of cancer, at the same site as the original (primary) tumor or in another location, after the tumor had disappeared. [NIH] Subconjunctival: Situated or occurring beneath the conjunctiva. [EU] Subcutaneous: Beneath the skin. [NIH] Systemic: Affecting the entire body. [NIH] Ultrasonography: A procedure in which sound waves (called ultrasound) are bounced off tissues and the echoes are converted to a picture (sonogram). [NIH]
Unresectable: Unable to be surgically removed. [NIH]
133
PART III. APPENDICES
ABOUT PART III Part III is a collection of appendices on general medical topics which may be of interest to patients with intraocular melanoma and related conditions.
Researching Your Medications 135
APPENDIX A. RESEARCHING YOUR MEDICATIONS Overview There are a number of sources available on new or existing medications which could be prescribed to patients with intraocular melanoma. While a number of hard copy or CD-Rom resources are available to patients and physicians for research purposes, a more flexible method is to use Internetbased databases. In this chapter, we will begin with a general overview of medications. We will then proceed to outline official recommendations on how you should view your medications. You may also want to research medications that you are currently taking for other conditions as they may interact with medications for intraocular melanoma. Research can give you information on the side effects, interactions, and limitations of prescription drugs used in the treatment of intraocular melanoma. Broadly speaking, there are two sources of information on approved medications: public sources and private sources. We will emphasize free-to-use public sources.
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Your Medications: The Basics77 The Agency for Health Care Research and Quality has published extremely useful guidelines on how you can best participate in the medication aspects of intraocular melanoma. Taking medicines is not always as simple as swallowing a pill. It can involve many steps and decisions each day. The AHCRQ recommends that patients with intraocular melanoma take part in treatment decisions. Do not be afraid to ask questions and talk about your concerns. By taking a moment to ask questions early, you may avoid problems later. Here are some points to cover each time a new medicine is prescribed: ·
Ask about all parts of your treatment, including diet changes, exercise, and medicines.
·
Ask about the risks and benefits of each medicine or other treatment you might receive.
·
Ask how often you or your doctor will check for side effects from a given medication.
Do not hesitate to ask what is important to you about your medicines. You may want a medicine with the fewest side effects, or the fewest doses to take each day. You may care most about cost, or how the medicine might affect how you live or work. Or, you may want the medicine your doctor believes will work the best. Telling your doctor will help him or her select the best treatment for you. Do not be afraid to “bother” your doctor with your concerns and questions about medications for intraocular melanoma. You can also talk to a nurse or a pharmacist. They can help you better understand your treatment plan. Feel free to bring a friend or family member with you when you visit your doctor. Talking over your options with someone you trust can help you make better choices, especially if you are not feeling well. Specifically, ask your doctor the following: ·
The name of the medicine and what it is supposed to do.
·
How and when to take the medicine, how much to take, and for how long.
·
What food, drinks, other medicines, or activities you should avoid while taking the medicine.
·
What side effects the medicine may have, and what to do if they occur.
77
This section is adapted from AHCRQ: http://www.ahcpr.gov/consumer/ncpiebro.htm.
Researching Your Medications 137
·
If you can get a refill, and how often.
·
About any terms or directions you do not understand.
·
What to do if you miss a dose.
·
If there is written information you can take home (most pharmacies have information sheets on your prescription medicines; some even offer large-print or Spanish versions).
Do not forget to tell your doctor about all the medicines you are currently taking (not just those for intraocular melanoma). This includes prescription medicines and the medicines that you buy over the counter. Then your doctor can avoid giving you a new medicine that may not work well with the medications you take now. When talking to your doctor, you may wish to prepare a list of medicines you currently take, the reason you take them, and how you take them. Be sure to include the following information for each: ·
Name of medicine
·
Reason taken
·
Dosage
·
Time(s) of day
Also include any over-the-counter medicines, such as: ·
Laxatives
·
Diet pills
·
Vitamins
·
Cold medicine
·
Aspirin or other pain, headache, or fever medicine
·
Cough medicine
·
Allergy relief medicine
·
Antacids
·
Sleeping pills
·
Others (include names)
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Learning More about Your Medications Because of historical investments by various organizations and the emergence of the Internet, it has become rather simple to learn about the medications your doctor has recommended for intraocular melanoma. One such source is the United States Pharmacopeia. In 1820, eleven physicians met in Washington, D.C. to establish the first compendium of standard drugs for the United States. They called this compendium the “U.S. Pharmacopeia (USP).” Today, the USP is a non-profit organization consisting of 800 volunteer scientists, eleven elected officials, and 400 representatives of state associations and colleges of medicine and pharmacy. The USP is located in Rockville, Maryland, and its home page is located at www.usp.org. The USP currently provides standards for over 3,700 medications. The resulting USP DIÒ Advice for the PatientÒ can be accessed through the National Library of Medicine of the National Institutes of Health. The database is partially derived from lists of federally approved medications in the Food and Drug Administration’s (FDA) Drug Approvals database.78 While the FDA database is rather large and difficult to navigate, the Phamacopeia is both user-friendly and free to use. It covers more than 9,000 prescription and over-the-counter medications. To access this database, simply type the following hyperlink into your Web browser: http://www.nlm.nih.gov/medlineplus/druginformation.html. To view examples of a given medication (brand names, category, description, preparation, proper use, precautions, side effects, etc.), simply follow the hyperlinks indicated within the United States Pharmacopoeia (USP). It is important to read the disclaimer by the USP (http://www.nlm.nih.gov/medlineplus/drugdisclaimer.html) before using the information provided. Of course, we as editors cannot be certain as to what medications you are taking. Therefore, we have compiled a list of medications associated with the treatment of intraocular melanoma. Once again, due to space limitations, we only list a sample of medications and provide hyperlinks to ample documentation (e.g. typical dosage, side effects, drug-interaction risks, etc.). The following drugs have been mentioned in the Pharmacopeia and other sources as being potentially applicable to intraocular melanoma:
Though cumbersome, the FDA database can be freely browsed at the following site: www.fda.gov/cder/da/da.htm.
78
Researching Your Medications 139
Carboplatin ·
Systemic - U.S. Brands: Paraplatin http://www.nlm.nih.gov/medlineplus/druginfo/carboplatinsyste mic202115.html
Doxorubicin ·
Systemic - U.S. Brands: Rubex http://www.nlm.nih.gov/medlineplus/druginfo/doxorubicinsyst emic202209.html
Commercial Databases In addition to the medications listed in the USP above, a number of commercial sites are available by subscription to physicians and their institutions. You may be able to access these sources from your local medical library or your doctor’s office.
Reuters Health Drug Database The Reuters Health Drug Database can be searched by keyword at the hyperlink: http://www.reutershealth.com/frame2/drug.html.
Mosby’s GenRx Mosby’s GenRx database (also available on CD-Rom and book format) covers 45,000 drug products including generics and international brands. It provides prescribing information, drug interactions, and patient information. Information can be obtained at the following hyperlink: http://www.genrx.com/Mosby/PhyGenRx/group.html.
Physicians Desk Reference The Physicians Desk Reference database (also available in CD-Rom and book format) is a full-text drug database. The database is searchable by brand name, generic name or by indication. It features multiple drug interactions reports. Information can be obtained at the following hyperlink: http://physician.pdr.net/physician/templates/en/acl/psuser_t.htm.
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Other Web Sites A number of additional Web sites discuss drug information. As an example, you may like to look at www.drugs.com which reproduces the information in the Pharmacopeia as well as commercial information. You may also want to consider the Web site of the Medical Letter, Inc. which allows users to download articles on various drugs and therapeutics for a nominal fee: http://www.medletter.com/.
Drug Development and Approval The following Web sites can be valuable resources when conducting research on the development and approval of new cancer drugs: ·
FDA Home Page: Search for drugs currently in development or those which have been recently approved by the FDA. http://redir.nci.nih.gov/cgibin/redir.pl?section=Cancerinfo&destURI=http://www.fda.gov/
·
Cancer Liaison Program: Answers questions from the public about drug approval processes, cancer clinical trials, and access to investigational therapies. http://redir.nci.nih.gov/cgibin/redir.pl?section=Cancerinfo&destURI=http://www.fda.gov/oashi/c ancer/cancer.html
·
Center for Drug Evaluation and Research http://redir.nci.nih.gov/cgibin/redir.pl?section=Cancerinfo&destURI=http://www.fda.gov/cder/
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Drug Approvals by Cancer Indications (Alphabetical List) http://redir.nci.nih.gov/cgibin/redir.pl?section=Cancerinfo&destURI=http://www.fda.gov/oashi/c ancer/cdrugalpha.html
·
Drug Approvals by Cancer Indications (Cancer Type) http://redir.nci.nih.gov/cgibin/redir.pl?section=Cancerinfo&destURI=http://www.fda.gov/oashi/c ancer/cdrugind.html
·
Electronic Orange Book of Approved Drug Products http://redir.nci.nih.gov/cgibin/redir.pl?section=Cancerinfo&destURI=http://www.fda.gov/cder/ob /default.htm
Researching Your Medications 141
·
Guidance Documents for Industry: Contains an archive of documents describing FDA policies on specific topics. http://redir.nci.nih.gov/cgibin/redir.pl?section=Cancerinfo&destURI=http://www.fda.gov/cder/gu idance/index.htm
·
Industry Collaboration: Provides information to industry on the process for getting new drugs into clinical trials. http://ctep.cancer.gov/industry/index.html
·
Investigator’s Handbook: Provides information to investigators on specific procedures related to clinical trial development. http://ctep.cancer.gov/handbook/index.html
·
Questions and Answers About NCI’s Natural Products Branch: A fact sheet that describes the functions of this branch, which collects and analyzes specimens of plant, marine, and microbial origin for possible anticancer properties. http://cis.nci.nih.gov/fact/7_33.htm
Understanding the Approval Process for New Cancer Drugs79 Since June 1996, about 80 new cancer-related drugs, or new uses for drugs already on the market, have been approved by the U.S. Food and Drug Administration (FDA), the division of the U.S. Department of Health and Human Services charged with ensuring the safety and effectiveness of new drugs before they can go on the market. (The FDA maintains an annotated online list of drugs approved for use with cancer since 1996.) Some of these drugs treat cancer, some alleviate pain and other symptoms, and, in one case, reduce the risk of invasive cancer in people who are considered highrisk. The FDA relied on the results of clinical trials in making every one of these approvals. Without reliable information about a drug’s effects on humans, it would be impossible to approve any drug for widespread use. When considering a new drug, the FDA faces two challenges: ·
First, making sure that the drug is safe and effective before it is made widely available;
·
Second, ensuring that drugs which show promise are made available as quickly as possible to the people they can help.
Adapted from the NCI: http://www.cancer.gov/clinical_trials/doc_header.aspx?viewid=d94cbfac-e478-4704-9052d8e8a3372b56.
79
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To deal with these challenges, the FDA maintains a rigorous review process but also has measures in place to make some drugs available in special cases. This aim of this section is to acquaint you with the drug approval process and point you to other resources for learning more about it.
The Role of the Federal Drug Administration (FDA) Approval is only one step in the drug development process. In fact, the FDA estimates that, on average, it takes eight and a half years to study and test a new drug before it can be approved for the general public. That includes early laboratory and animal testing, as well as the clinical trials that evaluate the drugs in humans. The FDA plays a key role at three main points in this process: ·
Determining whether or not a new drug shows enough promise to be given to people in clinical trials
·
Once clinical trials begin, deciding whether or not they should continue, based on reports of efficacy and adverse reactions
·
When clinical trials are completed, deciding whether or not the drug can be sold to the public and what its label should say about directions for use, side effects, warnings, and the like.
To make these decisions, the FDA must review studies submitted by the drug’s sponsor (usually the manufacturer), evaluate any adverse reports from preclinical studies and clinical trials (that is, reports of side effects or complications), and review the adequacy of the chemistry and manufacturing. This process is lengthy, but it is meant to ensure that only beneficial drugs with acceptable side effects will make their way into the hands of the public. At the same time, recent legislative mandates and streamlined procedures within the FDA have accelerated the approval of effective drugs, especially for serious illnesses such as cancer. In addition, specific provisions make some drugs available to patients with special needs even before the approval process is complete.
From Lab to Patient Care By law, the Food and Drug Administration (FDA) must review all test results for new drugs to ensure that products are safe and effective for specific uses. “Safe” does not mean that the drug is free of possible adverse side effects; rather, it means that the potential benefits have been determined
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to outweigh any risks. The testing process begins long before the first person takes the drug, with preliminary research and animal testing. If a drug proves promising in the lab, the drug company or sponsor must apply for FDA approval to test it in clinical trials involving people. For drugs, the application, called an Investigational New Drug (IND) Application, is sent through the Center for Drug Evaluation and Research’s (CDER) IND Review Process; for biological agents, the IND is sent to the Center for Biologics Evaluation and Research (CBER). Once the IND is approved by CDER or CBER, clinical trials can begin. If the drug makes it through the clinical trials process—that is, the studies show that it is superior to current drugs—the manufacturer must submit a New Drug Application (NDA) or (for biological agents) a Biologics License Application (BLA) to the FDA. (Biological agents, such as serums, vaccines, and cloned proteins, are manufactured from substances taken from living humans or animals.) This application must include: ·
The exact chemical makeup of the drug or biologic and the mechanisms by which it is effective
·
Results of animal studies
·
Results of clinical trials
·
How the drug or biologic is manufactured, processed, and packaged
·
Quality control standards
·
Samples of the product in the form(s) in which it is to be administered.
Once the FDA receives the NDA or BLA from the manufacturer or developer, the formal New Drug Application Review Process or Biologics/Product License Application Review Process begins. For an overview of the entire process from start to finish, see the CDER’s visual representation of The New Drug Development Process: Steps from Test Tube to New Drug Application Review, which is available for public viewing at the following Web address: http://www.fda.gov/cder/handbook/develop.htm.
Speed versus Safety in the Approval Process The FDA’s current goal is that no more than ten months will pass between the time that a complete application is submitted and the FDA takes action
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on it. But the process is not always smooth. Sometimes FDA’s external advisory panels call for additional research or data. In other cases, the FDA staff asks for more information or revised studies. Some new drug approvals have taken as little as 42 days; other more difficult NDAs have spent years in the approval process.
Setting Priorities The order in which NDAs are assessed by the FDA is determined by a classification system designed to give priority to drugs with the greatest potential benefits. All drugs that offer significant medical advances over existing therapies for any disease are considered “priority” drugs in the approval process. NDAs for cancer treatment drugs are reviewed for this status primarily by the Division of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research (CDER). For Biologic License Applications (vaccines, blood products, and medicines made from animal products), the Center for Biologics Evaluation and Research (CBER) provides additional regulation and oversight.
Expert Advice The FDA relies on a system of independent advisory committees, made up of professionals from outside the agency, for expert advice and guidance in making sound decisions about drug approval. Each committee meets as needed to weigh available evidence and assess the safety, effectiveness, and appropriate use of products considered for approval. In addition, these committees provide advice about general criteria for evaluation and scientific issues not related to specific products. The Oncologic Drugs Advisory Committee (ODAC) meets regularly to provide expert advice on cancer-related treatments and preventive drugs. Each committee is composed of representatives from the research science and medical fields. At least one member on every advisory committee must represent the consumer perspective.
Final Approval As the FDA looks at all the data submitted and the results of its own review, it applies two benchmark questions to each application for drug approval:
Researching Your Medications 145
·
Do the results of well-controlled studies provide substantial evidence of effectiveness?
·
Do the results show the product is safe under the conditions of use in the proposed labeling? In this context, “safe” means that potential benefits have been determined to outweigh any risks.
Continued Vigilance The FDA’s responsibility for new drug treatments does not stop with final approval. The Office of Compliance in the Center for Drug Evaluation and Research (CDER) implements and tracks programs to make sure manufacturers comply with current standards and practice regulations. CDER’s Office of Drug Marketing, Advertising, and Communication monitors new drug advertising to make sure it is truthful and complete. At the Center for Biologic Evaluation and Research, biologics are followed with the same vigilance after approval. And through a system called MedWatch, the FDA gets feedback from health professionals and consumers on how the new drugs are working, any adverse reactions, and potential problems in labeling and dosage.
Online FDA Resources The following information from the FDA should help you better understand the drug approval process: ·
Center for Drug Evaluation http://www.fda.gov/cder/handbook
·
From Test Tube to Patient: New Drug Development in the U.S. – a special January 1995 issue of the magazine FDA Consumer: http://www.fda.gov/fdac/special/newdrug/ndd_toc.html
·
Milestones in U.S. Food and Drug Law History: http://www.fda.gov/opacom/backgrounders/miles.html
·
Drug Approvals for Cancer Indications: http://www.fda.gov/oashi/cancer/cdrug.html
and
Research:
Getting Drugs to Patients Who Need Them Clinical trials provide the most important information used by the FDA in determining whether a new drug shows “substantial evidence of
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effectiveness,” or whether an already-approved drug can be used effectively in new ways (for example, to treat or prevent other types of cancer, or at a different dosage). The FDA must certify that a drug has shown promise in laboratory and animal trials before human testing can begin. The trials process includes three main stages and involves continuous review, which ensures that the sponsor can stop the study early if major problems develop or unexpected levels of treatment benefit are found. As with all clinical trials, benefits and risks must be carefully weighed by the researchers conducting the study and the patients who decide to participate. Not everyone is eligible to participate in a clinical trial. Some patients do not fit the exact requirements for studies, some have rare forms of cancer for which only a limited number of studies are underway, and others are too ill to participate. Working with the NCI and other sponsors, the FDA has established special conditions under which a patient and his or her physician can apply to receive cancer drugs that have not yet been through the approval process. In the past, these special case applications for new drugs were grouped under the name “compassionate uses.” More recently, such uses have expanded to include more patients and more categories of investigational drugs.
Access to Investigational Drugs The process of new drug development has many parts. In the United States, until a drug has been approved by the FDA, it can generally be obtained only through several mechanisms: enrollment in a clinical trial studying the drug, an expanded access program or special exemption/compassionate use programs. For more information about investigational drugs, see “Questions and Answers: Access to Investigational Drugs“ at http://www.cancer.gov/cancer_information/doc_img.aspx?viewid=74b62d8 4-e135-451f-9bc9-d54358ede947.
“Group C” Drugs In the 1970s, researchers from the NCI became concerned about the lag between the date when an investigational drug was found to have antitumor activity and the time that drug became available on the market. Working with the FDA, the NCI established the “Group C” classification to allow access to drugs with reproducible activity. Group C drugs are provided to properly trained physicians who have registered using a special form to assure that their patient qualifies under guideline protocols for the
Researching Your Medications 147
drug. Each Group C drug protocol specifies patient eligibility, reporting methodology, and drug use. Not only does Group C designation (now called Group C/Treatment INDs) speed new drugs to patients who need them most, but the process also allows the NCI to gather important information on the safety as well as activity of the drugs in the settings in which they will be most used after final FDA approval. Drugs are placed in the Group C category by agreement between the FDA and the NCI. Group C drugs are always provided free of charge, and the Health Care Financing Administration provides coverage for care associated with Group C therapy.
Treatment INDs In 1987, the FDA began authorizing the use of new drugs still in the development process to treat certain seriously ill patients. In these cases, the process is referred to as a treatment investigational new drug application (Treatment IND). Clinical trials of the new drug must already be underway and have demonstrated positive results that are reproducible. The FDA sets guidelines about what constitutes serious and life-threatening illnesses, how much must already be known about a drug’s side effects and benefits, and where physicians can obtain the drug for treatment. For many seriously ill patients, the risks associated with taking a not-yet-completely proven drug are outweighed by the possible benefits.
Accelerated Approval “Accelerated approval” is the short-hand term for the FDA’s new review system which, in the 1990s, has been used to ensure rapid approval while at the same time putting new safeguards into place. Accelerated approval is based on “surrogate endpoint” judgments: FDA can grant marketing approval to drugs and treatments that, according to certain indicators, prove they are likely to have beneficial effects on a disease or condition, even before such direct benefits have been shown clinically.
Contraindications and Interactions (Hidden Dangers) Some of the medications mentioned in the previous discussions can be problematic for patients with intraocular melanoma--not because they are used in the treatment process, but because of contraindications, or side effects. Medications with contraindications are those that could react with drugs used to treat intraocular melanoma or potentially create deleterious
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side effects in patients with intraocular melanoma. You should ask your physician about any contraindications, especially as these might apply to other medications that you may be taking for common ailments. Drug-drug interactions occur when two or more drugs react with each other. This drug-drug interaction may cause you to experience an unexpected side effect. Drug interactions may make your medications less effective, cause unexpected side effects, or increase the action of a particular drug. Some drug interactions can even be harmful to you. Be sure to read the label every time you use a nonprescription or prescription drug, and take the time to learn about drug interactions. These precautions may be critical to your health. You can reduce the risk of potentially harmful drug interactions and side effects with a little bit of knowledge and common sense. Drug labels contain important information about ingredients, uses, warnings, and directions which you should take the time to read and understand. Labels also include warnings about possible drug interactions. Further, drug labels may change as new information becomes available. This is why it’s especially important to read the label every time you use a medication. When your doctor prescribes a new drug, discuss all over-thecounter and prescription medications, dietary supplements, vitamins, botanicals, minerals and herbals you take as well as the foods you eat. Ask your pharmacist for the package insert for each prescription drug you take. The package insert provides more information about potential drug interactions.
A Final Warning At some point, you may hear of alternative medications from friends, relatives, or in the news media. Advertisements may suggest that certain alternative drugs can produce positive results for patients with intraocular melanoma. Exercise caution--some of these drugs may have fraudulent claims, and others may actually hurt you. The Food and Drug Administration (FDA) is the official U.S. agency charged with discovering which medications are likely to improve the health of patients with intraocular melanoma. The FDA warns patients to watch out for80: ·
80
Secret formulas (real scientists share what they know)
This section has been adapted from http://www.fda.gov/opacom/lowlit/medfraud.html.
Researching Your Medications 149
·
Amazing breakthroughs or miracle cures (real breakthroughs don’t happen very often; when they do, real scientists do not call them amazing or miracles)
·
Quick, painless, or guaranteed cures
·
If it sounds too good to be true, it probably isn’t true.
If you have any questions about any kind of medical treatment, the FDA may have an office near you. Look for their number in the blue pages of the phone book. You can also contact the FDA through its toll-free number, 1888-INFO-FDA (1-888-463-6332), or on the World Wide Web at www.fda.gov.
General References In addition to the resources provided earlier in this chapter, the following general references describe medications (sorted alphabetically by title; hyperlinks provide rankings, information and reviews at Amazon.com): ·
Antifolate Drugs in Cancer Therapy (Cancer Drug Discovery and Development) by Ann L. Jackman (Editor); Hardcover: 480 pages; (March 1999), Humana Press; ISBN: 0896035964; http://www.amazon.com/exec/obidos/ASIN/0896035964/icongroupinterna
·
Consumers Guide to Cancer Drugs by Gail M. Wilkes, et al; Paperback 448 pages, 1st edition (January 15, 2000), Jones & Bartlett Publishing; ISBN: 0763711705; http://www.amazon.com/exec/obidos/ASIN/0763711705/icongroupinterna
·
Patient Education Guide to Oncology Drugs (Book with CD-ROM) by Gail M. Wilkes, et al; CD-ROM - 447 pages, 1st edition (January 15, 2000), Jones & Bartlett Publishing; ISBN: 076371173X; http://www.amazon.com/exec/obidos/ASIN/076371173X/icongroupinterna
·
The Role of Multiple Intensification in Medical Oncology by M. S. Aapro (Editor), D. Maraninchi (Editor); Hardcover (June 1998), Springer Verlag; ISBN: 3540635432; http://www.amazon.com/exec/obidos/ASIN/3540635432/icongroupinterna
Finding Medical Libraries 151
APPENDIX B. FINDING MEDICAL LIBRARIES Overview At a medical library you can find medical texts and reference books, consumer health publications, specialty newspapers and magazines, as well as medical journals. In this appendix, we show you how to quickly find a medical library in your area.
Preparation Before going to the library, highlight the references mentioned in this sourcebook that you find interesting. Focus on those items that are not available via the Internet, and ask the reference librarian for help with your search. He or she may know of additional resources that could be helpful to you. Most importantly, your local public library and medical libraries have Interlibrary Loan programs with the National Library of Medicine (NLM), one of the largest medical collections in the world. According to the NLM, most of the literature in the general and historical collections of the National Library of Medicine is available on interlibrary loan to any library. NLM’s interlibrary loan services are only available to libraries. If you would like to access NLM medical literature, then visit a library in your area that can request the publications for you.81
81
Adapted from the NLM: http://www.nlm.nih.gov/psd/cas/interlibrary.html.
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Finding a Local Medical Library The quickest method to locate medical libraries is to use the Internet-based directory published by the National Network of Libraries of Medicine (NN/LM). This network includes 4626 members and affiliates that provide many services to librarians, health professionals, and the public. To find a library in your area, simply visit http://nnlm.gov/members/adv.html or call 1-800-338-7657.
Medical Libraries Open to the Public In addition to the NN/LM, the National Library of Medicine (NLM) lists a number of libraries that are generally open to the public and have reference facilities. The following is the NLM’s list plus hyperlinks to each library Web site. These Web pages can provide information on hours of operation and other restrictions. The list below is a small sample of libraries recommended by the National Library of Medicine (sorted alphabetically by name of the U.S. state or Canadian province where the library is located):82 ·
Alabama: Health InfoNet of Jefferson County (Jefferson County Library Cooperative, Lister Hill Library of the Health Sciences), http://www.uab.edu/infonet/
·
Alabama: Richard M. Scrushy Library (American Sports Medicine Institute), http://www.asmi.org/LIBRARY.HTM
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Arizona: Samaritan Regional Medical Center: The Learning Center (Samaritan Health System, Phoenix, Arizona), http://www.samaritan.edu/library/bannerlibs.htm
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California: Kris Kelly Health Information Center (St. Joseph Health System), http://www.humboldt1.com/~kkhic/index.html
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California: Community Health Library of Los Gatos (Community Health Library of Los Gatos), http://www.healthlib.org/orgresources.html
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California: Consumer Health Program and Services (CHIPS) (County of Los Angeles Public Library, Los Angeles County Harbor-UCLA Medical Center Library) - Carson, CA, http://www.colapublib.org/services/chips.html
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California: Gateway Health Library (Sutter Gould Medical Foundation)
·
California: Health Library (Stanford University Medical Center), http://www-med.stanford.edu/healthlibrary/
82
Abstracted from http://www.nlm.nih.gov/medlineplus/libraries.html.
Finding Medical Libraries 153
·
California: Patient Education Resource Center - Health Information and Resources (University of California, San Francisco), http://sfghdean.ucsf.edu/barnett/PERC/default.asp
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California: Redwood Health Library (Petaluma Health Care District), http://www.phcd.org/rdwdlib.html
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California: San José PlaneTree Health Library, http://planetreesanjose.org/
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California: Sutter Resource Library (Sutter Hospitals Foundation), http://go.sutterhealth.org/comm/resc-library/sac-resources.html
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California: University of California, Davis. Health Sciences Libraries
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California: ValleyCare Health Library & Ryan Comer Cancer Resource Center (ValleyCare Health System), http://www.valleycare.com/library.html
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California: Washington Community Health Resource Library (Washington Community Health Resource Library), http://www.healthlibrary.org/
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Colorado: William V. Gervasini Memorial Library (Exempla Healthcare), http://www.exempla.org/conslib.htm
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Connecticut: Hartford Hospital Health Science Libraries (Hartford Hospital), http://www.harthosp.org/library/
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Connecticut: Healthnet: Connecticut Consumer Health Information Center (University of Connecticut Health Center, Lyman Maynard Stowe Library), http://library.uchc.edu/departm/hnet/
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Connecticut: Waterbury Hospital Health Center Library (Waterbury Hospital), http://www.waterburyhospital.com/library/consumer.shtml
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Delaware: Consumer Health Library (Christiana Care Health System, Eugene du Pont Preventive Medicine & Rehabilitation Institute), http://www.christianacare.org/health_guide/health_guide_pmri_health _info.cfm
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Delaware: Lewis B. Flinn Library (Delaware Academy of Medicine), http://www.delamed.org/chls.html
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Georgia: Family Resource Library (Medical College of Georgia), http://cmc.mcg.edu/kids_families/fam_resources/fam_res_lib/frl.htm
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Georgia: Health Resource Center (Medical Center of Central Georgia), http://www.mccg.org/hrc/hrchome.asp
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Hawaii: Hawaii Medical Library: Consumer Health Information Service (Hawaii Medical Library), http://hml.org/CHIS/
154 Intraocular Melanoma
·
Idaho: DeArmond Consumer Health Library (Kootenai Medical Center), http://www.nicon.org/DeArmond/index.htm
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Illinois: Health Learning Center of Northwestern Memorial Hospital (Northwestern Memorial Hospital, Health Learning Center), http://www.nmh.org/health_info/hlc.html
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Illinois: Medical Library (OSF Saint Francis Medical Center), http://www.osfsaintfrancis.org/general/library/
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Kentucky: Medical Library - Services for Patients, Families, Students & the Public (Central Baptist Hospital), http://www.centralbap.com/education/community/library.htm
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Kentucky: University of Kentucky - Health Information Library (University of Kentucky, Chandler Medical Center, Health Information Library), http://www.mc.uky.edu/PatientEd/
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Louisiana: Alton Ochsner Medical Foundation Library (Alton Ochsner Medical Foundation), http://www.ochsner.org/library/
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Louisiana: Louisiana State University Health Sciences Center Medical Library-Shreveport, http://lib-sh.lsuhsc.edu/
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Maine: Franklin Memorial Hospital Medical Library (Franklin Memorial Hospital), http://www.fchn.org/fmh/lib.htm
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Maine: Gerrish-True Health Sciences Library (Central Maine Medical Center), http://www.cmmc.org/library/library.html
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Maine: Hadley Parrot Health Science Library (Eastern Maine Healthcare), http://www.emh.org/hll/hpl/guide.htm
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Maine: Maine Medical Center Library (Maine Medical Center), http://www.mmc.org/library/
·
Maine: Parkview Hospital, http://www.parkviewhospital.org/communit.htm#Library
·
Maine: Southern Maine Medical Center Health Sciences Library (Southern Maine Medical Center), http://www.smmc.org/services/service.php3?choice=10
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Maine: Stephens Memorial Hospital Health Information Library (Western Maine Health), http://www.wmhcc.com/hil_frame.html
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Manitoba, Canada: Consumer & Patient Health Information Service (University of Manitoba Libraries), http://www.umanitoba.ca/libraries/units/health/reference/chis.html
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Manitoba, Canada: J.W. Crane Memorial Library (Deer Lodge Centre), http://www.deerlodge.mb.ca/library/libraryservices.shtml
Finding Medical Libraries 155
·
Maryland: Health Information Center at the Wheaton Regional Library (Montgomery County, Md., Dept. of Public Libraries, Wheaton Regional Library), http://www.mont.lib.md.us/healthinfo/hic.asp
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Massachusetts: Baystate Medical Center Library (Baystate Health System), http://www.baystatehealth.com/1024/
·
Massachusetts: Boston University Medical Center Alumni Medical Library (Boston University Medical Center), http://medlibwww.bu.edu/library/lib.html
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Massachusetts: Lowell General Hospital Health Sciences Library (Lowell General Hospital), http://www.lowellgeneral.org/library/HomePageLinks/WWW.htm
·
Massachusetts: Paul E. Woodard Health Sciences Library (New England Baptist Hospital), http://www.nebh.org/health_lib.asp
·
Massachusetts: St. Luke’s Hospital Health Sciences Library (St. Luke’s Hospital), http://www.southcoast.org/library/
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Massachusetts: Treadwell Library Consumer Health Reference Center (Massachusetts General Hospital), http://www.mgh.harvard.edu/library/chrcindex.html
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Massachusetts: UMass HealthNet (University of Massachusetts Medical School), http://healthnet.umassmed.edu/
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Michigan: Botsford General Hospital Library - Consumer Health (Botsford General Hospital, Library & Internet Services), http://www.botsfordlibrary.org/consumer.htm
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Michigan: Helen DeRoy Medical Library (Providence Hospital and Medical Centers), http://www.providence-hospital.org/library/
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Michigan: Marquette General Hospital - Consumer Health Library (Marquette General Hospital, Health Information Center), http://www.mgh.org/center.html
·
Michigan: Patient Education Resouce Center - University of Michigan Cancer Center (University of Michigan Comprehensive Cancer Center), http://www.cancer.med.umich.edu/learn/leares.htm
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Michigan: Sladen Library & Center for Health Information Resources Consumer Health Information, http://www.sladen.hfhs.org/library/consumer/index.html
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Montana: Center for Health Information (St. Patrick Hospital and Health Sciences Center), http://www.saintpatrick.org/chi/librarydetail.php3?ID=41
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·
National: Consumer Health Library Directory (Medical Library Association, Consumer and Patient Health Information Section), http://caphis.mlanet.org/directory/index.html
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National: National Network of Libraries of Medicine (National Library of Medicine) - provides library services for health professionals in the United States who do not have access to a medical library, http://nnlm.gov/
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National: NN/LM List of Libraries Serving the Public (National Network of Libraries of Medicine), http://nnlm.gov/members/
·
Nevada: Health Science Library, West Charleston Library (Las Vegas Clark County Library District), http://www.lvccld.org/special_collections/medical/index.htm
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New Hampshire: Dartmouth Biomedical Libraries (Dartmouth College Library), http://www.dartmouth.edu/~biomed/resources.htmld/conshealth.htmld/
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New Jersey: Consumer Health Library (Rahway Hospital), http://www.rahwayhospital.com/library.htm
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New Jersey: Dr. Walter Phillips Health Sciences Library (Englewood Hospital and Medical Center), http://www.englewoodhospital.com/links/index.htm
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New Jersey: Meland Foundation (Englewood Hospital and Medical Center), http://www.geocities.com/ResearchTriangle/9360/
·
New York: Choices in Health Information (New York Public Library) NLM Consumer Pilot Project participant, http://www.nypl.org/branch/health/links.html
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New York: Health Information Center (Upstate Medical University, State University of New York), http://www.upstate.edu/library/hic/
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New York: Health Sciences Library (Long Island Jewish Medical Center), http://www.lij.edu/library/library.html
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New York: ViaHealth Medical Library (Rochester General Hospital), http://www.nyam.org/library/
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Ohio: Consumer Health Library (Akron General Medical Center, Medical & Consumer Health Library), http://www.akrongeneral.org/hwlibrary.htm
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Oklahoma: Saint Francis Health System Patient/Family Resource Center (Saint Francis Health System), http://www.sfhtulsa.com/patientfamilycenter/default.asp
Finding Medical Libraries 157
·
Oregon: Planetree Health Resource Center (Mid-Columbia Medical Center), http://www.mcmc.net/phrc/
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Pennsylvania: Community Health Information Library (Milton S. Hershey Medical Center), http://www.hmc.psu.edu/commhealth/
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Pennsylvania: Community Health Resource Library (Geisinger Medical Center), http://www.geisinger.edu/education/commlib.shtml
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Pennsylvania: HealthInfo Library (Moses Taylor Hospital), http://www.mth.org/healthwellness.html
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Pennsylvania: Hopwood Library (University of Pittsburgh, Health Sciences Library System), http://www.hsls.pitt.edu/chi/hhrcinfo.html
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Pennsylvania: Koop Community Health Information Center (College of Physicians of Philadelphia), http://www.collphyphil.org/kooppg1.shtml
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Pennsylvania: Learning Resources Center - Medical Library (Susquehanna Health System), http://www.shscares.org/services/lrc/index.asp
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Pennsylvania: Medical Library (UPMC Health System), http://www.upmc.edu/passavant/library.htm
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Quebec, Canada: Medical Library (Montreal General Hospital), http://ww2.mcgill.ca/mghlib/
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South Dakota: Rapid City Regional Hospital - Health Information Center (Rapid City Regional Hospital, Health Information Center), http://www.rcrh.org/education/LibraryResourcesConsumers.htm
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Texas: Houston HealthWays (Houston Academy of Medicine-Texas Medical Center Library), http://hhw.library.tmc.edu/
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Texas: Matustik Family Resource Center (Cook Children’s Health Care System), http://www.cookchildrens.com/Matustik_Library.html
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Washington: Community Health Library (Kittitas Valley Community Hospital), http://www.kvch.com/
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Washington: Southwest Washington Medical Center Library (Southwest Washington Medical Center), http://www.swmedctr.com/Home/
Your Rights and Insurance 159
APPENDIX C. YOUR RIGHTS AND INSURANCE Overview Any patient with intraocular melanoma faces a series of issues related more to the healthcare industry than to the medical condition itself. This appendix covers two important topics in this regard: your rights and responsibilities as a patient, and how to get the most out of your medical insurance plan.
Your Rights as a Patient The President’s Advisory Commission on Consumer Protection and Quality in the Healthcare Industry has created the following summary of your rights as a patient.83 Information Disclosure Consumers have the right to receive accurate, easily understood information. Some consumers require assistance in making informed decisions about health plans, health professionals, and healthcare facilities. Such information includes: ·
Health plans. Covered benefits, cost-sharing, and procedures for resolving complaints, licensure, certification, and accreditation status, comparable measures of quality and consumer satisfaction, provider network composition, the procedures that govern access to specialists and emergency services, and care management information.
83Adapted
from Consumer Bill of Rights and Responsibilities: http://www.hcqualitycommission.gov/press/cbor.html#head1.
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·
Health professionals. Education, board certification, and recertification, years of practice, experience performing certain procedures, and comparable measures of quality and consumer satisfaction.
·
Healthcare facilities. Experience in performing certain procedures and services, accreditation status, comparable measures of quality, worker, and consumer satisfaction, and procedures for resolving complaints.
·
Consumer assistance programs. Programs must be carefully structured to promote consumer confidence and to work cooperatively with health plans, providers, payers, and regulators. Desirable characteristics of such programs are sponsorship that ensures accountability to the interests of consumers and stable, adequate funding.
Choice of Providers and Plans Consumers have the right to a choice of healthcare providers that is sufficient to ensure access to appropriate high-quality healthcare. To ensure such choice, the Commission recommends the following: ·
Provider network adequacy. All health plan networks should provide access to sufficient numbers and types of providers to assure that all covered services will be accessible without unreasonable delay -including access to emergency services 24 hours a day and 7 days a week. If a health plan has an insufficient number or type of providers to provide a covered benefit with the appropriate degree of specialization, the plan should ensure that the consumer obtains the benefit outside the network at no greater cost than if the benefit were obtained from participating providers.
·
Women’s health services. Women should be able to choose a qualified provider offered by a plan -- such as gynecologists, certified nurse midwives, and other qualified healthcare providers -- for the provision of covered care necessary to provide routine and preventative women’s healthcare services.
·
Access to specialists. Consumers with complex or serious medical conditions who require frequent specialty care should have direct access to a qualified specialist of their choice within a plan’s network of providers. Authorizations, when required, should be for an adequate number of direct access visits under an approved treatment plan.
·
Transitional care. Consumers who are undergoing a course of treatment for a chronic or disabling condition (or who are in the second or third trimester of a pregnancy) at the time they involuntarily change health
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plans or at a time when a provider is terminated by a plan for other than cause should be able to continue seeing their current specialty providers for up to 90 days (or through completion of postpartum care) to allow for transition of care. ·
Choice of health plans. Public and private group purchasers should, wherever feasible, offer consumers a choice of high-quality health insurance plans.
Access to Emergency Services Consumers have the right to access emergency healthcare services when and where the need arises. Health plans should provide payment when a consumer presents to an emergency department with acute symptoms of sufficient severity--including severe pain--such that a “prudent layperson” could reasonably expect the absence of medical attention to result in placing that consumer’s health in serious jeopardy, serious impairment to bodily functions, or serious dysfunction of any bodily organ or part.
Participation in Treatment Decisions Consumers have the right and responsibility to fully participate in all decisions related to their healthcare. Consumers who are unable to fully participate in treatment decisions have the right to be represented by parents, guardians, family members, or other conservators. Physicians and other health professionals should: ·
Provide patients with sufficient information and opportunity to decide among treatment options consistent with the informed consent process.
·
Discuss all treatment options with a patient in a culturally competent manner, including the option of no treatment at all.
·
Ensure that persons with disabilities have effective communications with members of the health system in making such decisions.
·
Discuss all current treatments a consumer may be undergoing.
·
Discuss all risks, nontreatment.
·
Give patients the opportunity to refuse treatment and to express preferences about future treatment decisions.
benefits,
and
consequences
to
treatment
or
162 Intraocular Melanoma
·
Discuss the use of advance directives -- both living wills and durable powers of attorney for healthcare -- with patients and their designated family members.
·
Abide by the decisions made by their patients and/or their designated representatives consistent with the informed consent process.
Health plans, health providers, and healthcare facilities should: ·
Disclose to consumers factors -- such as methods of compensation, ownership of or interest in healthcare facilities, or matters of conscience -that could influence advice or treatment decisions.
·
Assure that provider contracts do not contain any so-called “gag clauses” or other contractual mechanisms that restrict healthcare providers’ ability to communicate with and advise patients about medically necessary treatment options.
·
Be prohibited from penalizing or seeking retribution against healthcare professionals or other health workers for advocating on behalf of their patients.
Respect and Nondiscrimination Consumers have the right to considerate, respectful care from all members of the healthcare industry at all times and under all circumstances. An environment of mutual respect is essential to maintain a quality healthcare system. To assure that right, the Commission recommends the following: ·
Consumers must not be discriminated against in the delivery of healthcare services consistent with the benefits covered in their policy, or as required by law, based on race, ethnicity, national origin, religion, sex, age, mental or physical disability, sexual orientation, genetic information, or source of payment.
·
Consumers eligible for coverage under the terms and conditions of a health plan or program, or as required by law, must not be discriminated against in marketing and enrollment practices based on race, ethnicity, national origin, religion, sex, age, mental or physical disability, sexual orientation, genetic information, or source of payment. Confidentiality of Health Information
Consumers have the right to communicate with healthcare providers in confidence and to have the confidentiality of their individually identifiable
Your Rights and Insurance 163
healthcare information protected. Consumers also have the right to review and copy their own medical records and request amendments to their records. Complaints and Appeals Consumers have the right to a fair and efficient process for resolving differences with their health plans, healthcare providers, and the institutions that serve them, including a rigorous system of internal review and an independent system of external review. A free copy of the Patient’s Bill of Rights is available from the American Hospital Association.84
Patient Responsibilities Treatment is a two-way street between you and your healthcare providers. To underscore the importance of finance in modern healthcare as well as your responsibility for the financial aspects of your care, the President’s Advisory Commission on Consumer Protection and Quality in the Healthcare Industry has proposed that patients understand the following “Consumer Responsibilities.”85 In a healthcare system that protects consumers’ rights, it is reasonable to expect and encourage consumers to assume certain responsibilities. Greater individual involvement by the consumer in his or her care increases the likelihood of achieving the best outcome and helps support a quality-oriented, cost-conscious environment. Such responsibilities include: ·
Take responsibility for maximizing healthy habits such as exercising, not smoking, and eating a healthy diet.
·
Work collaboratively with healthcare providers in developing and carrying out agreed-upon treatment plans.
·
Disclose relevant information and clearly communicate wants and needs.
·
Use your health insurance plan’s internal complaint and appeal processes to address your concerns.
·
Avoid knowingly spreading disease.
To order your free copy of the Patient’s Bill of Rights, telephone 312-422-3000 or visit the American Hospital Association’s Web site: http://www.aha.org. Click on “Resource Center,” go to “Search” at bottom of page, and then type in “Patient’s Bill of Rights.” The Patient’s Bill of Rights is also available from Fax on Demand, at 312-422-2020, document number 471124. 85 Adapted from http://www.hcqualitycommission.gov/press/cbor.html#head1. 84
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·
Recognize the reality of risks, the limits of the medical science, and the human fallibility of the healthcare professional.
·
Be aware of a healthcare provider’s obligation to be reasonably efficient and equitable in providing care to other patients and the community.
·
Become knowledgeable about your health plan’s coverage and options (when available) including all covered benefits, limitations, and exclusions, rules regarding use of network providers, coverage and referral rules, appropriate processes to secure additional information, and the process to appeal coverage decisions.
·
Show respect for other patients and health workers.
·
Make a good-faith effort to meet financial obligations.
·
Abide by administrative and operational procedures of health plans, healthcare providers, and Government health benefit programs.
Choosing an Insurance Plan There are a number of official government agencies that help consumers understand their healthcare insurance choices.86 The U.S. Department of Labor, in particular, recommends ten ways to make your health benefits choices work best for you.87 1. Your options are important. There are many different types of health benefit plans. Find out which one your employer offers, then check out the plan, or plans, offered. Your employer’s human resource office, the health plan administrator, or your union can provide information to help you match your needs and preferences with the available plans. The more information you have, the better your healthcare decisions will be. 2. Reviewing the benefits available. Do the plans offered cover preventive care, well-baby care, vision or dental care? Are there deductibles? Answers to these questions can help determine the out-of-pocket expenses you may face. Matching your needs and those of your family members will result in the best possible benefits. Cheapest may not always be best. Your goal is high quality health benefits.
More information about quality across programs is provided at the following AHRQ Web site: http://www.ahrq.gov/consumer/qntascii/qnthplan.htm. 87 Adapted from the Department of Labor: http://www.dol.gov/dol/pwba/public/pubs/health/top10-text.html. 86
Your Rights and Insurance 165
3. Look for quality. The quality of healthcare services varies, but quality can be measured. You should consider the quality of healthcare in deciding among the healthcare plans or options available to you. Not all health plans, doctors, hospitals and other providers give the highest quality care. Fortunately, there is quality information you can use right now to help you compare your healthcare choices. Find out how you can measure quality. Consult the U.S. Department of Health and Human Services publication “Your Guide to Choosing Quality Health Care” on the Internet at www.ahcpr.gov/consumer. 4. Your plan’s summary plan description (SPD) provides a wealth of information. Your health plan administrator can provide you with a copy of your plan’s SPD. It outlines your benefits and your legal rights under the Employee Retirement Income Security Act (ERISA), the federal law that protects your health benefits. It should contain information about the coverage of dependents, what services will require a co-pay, and the circumstances under which your employer can change or terminate a health benefits plan. Save the SPD and all other health plan brochures and documents, along with memos or correspondence from your employer relating to health benefits. 5. Assess your benefit coverage as your family status changes. Marriage, divorce, childbirth or adoption, and the death of a spouse are all life events that may signal a need to change your health benefits. You, your spouse and dependent children may be eligible for a special enrollment period under provisions of the Health Insurance Portability and Accountability Act (HIPAA). Even without life-changing events, the information provided by your employer should tell you how you can change benefits or switch plans, if more than one plan is offered. If your spouse’s employer also offers a health benefits package, consider coordinating both plans for maximum coverage. 6. Changing jobs and other life events can affect your health benefits. Under the Consolidated Omnibus Budget Reconciliation Act (COBRA), you, your covered spouse, and your dependent children may be eligible to purchase extended health coverage under your employer’s plan if you lose your job, change employers, get divorced, or upon occurrence of certain other events. Coverage can range from 18 to 36 months depending on your situation. COBRA applies to most employers with 20 or more workers and requires your plan to notify you of your rights. Most plans require eligible individuals to make their COBRA election within 60 days of the plan’s notice. Be sure to follow up with your plan sponsor if you don’t receive notice, and make sure you respond within the allotted time.
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7. HIPAA can also help if you are changing jobs, particularly if you have a medical condition. HIPAA generally limits pre-existing condition exclusions to a maximum of 12 months (18 months for late enrollees). HIPAA also requires this maximum period to be reduced by the length of time you had prior “creditable coverage.” You should receive a certificate documenting your prior creditable coverage from your old plan when coverage ends. 8. Plan for retirement. Before you retire, find out what health benefits, if any, extend to you and your spouse during your retirement years. Consult with your employer’s human resources office, your union, the plan administrator, and check your SPD. Make sure there is no conflicting information among these sources about the benefits you will receive or the circumstances under which they can change or be eliminated. With this information in hand, you can make other important choices, like finding out if you are eligible for Medicare and Medigap insurance coverage. 9. Know how to file an appeal if your health benefits claim is denied. Understand how your plan handles grievances and where to make appeals of the plan’s decisions. Keep records and copies of correspondence. Check your health benefits package and your SPD to determine who is responsible for handling problems with benefit claims. Contact PWBA for customer service assistance if you are unable to obtain a response to your complaint. 10. You can take steps to improve the quality of the healthcare and the health benefits you receive. Look for and use things like Quality Reports and Accreditation Reports whenever you can. Quality reports may contain consumer ratings -- how satisfied consumers are with the doctors in their plan, for instance-- and clinical performance measures -- how well a healthcare organization prevents and treats illness. Accreditation reports provide information on how accredited organizations meet national standards, and often include clinical performance measures. Look for these quality measures whenever possible. Consult “Your Guide to Choosing Quality Health Care” on the Internet at www.ahcpr.gov/consumer.
Medicare and Medicaid Illness strikes both rich and poor families. For low-income families, Medicaid is available to defer the costs of treatment. The Health Care Financing Administration (HCFA) administers Medicare, the nation’s largest health insurance program, which covers 39 million Americans. In the following pages, you will learn the basics about Medicare insurance as well as useful
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contact information on how to find more in-depth information about Medicaid.88
Who is Eligible for Medicare? Generally, you are eligible for Medicare if you or your spouse worked for at least 10 years in Medicare-covered employment and you are 65 years old and a citizen or permanent resident of the United States. You might also qualify for coverage if you are under age 65 but have a disability or EndStage Renal disease (permanent kidney failure requiring dialysis or transplant). Here are some simple guidelines: You can get Part A at age 65 without having to pay premiums if: ·
You are already receiving retirement benefits from Social Security or the Railroad Retirement Board.
·
You are eligible to receive Social Security or Railroad benefits but have not yet filed for them.
·
You or your spouse had Medicare-covered government employment.
If you are under 65, you can get Part A without having to pay premiums if: ·
You have received Social Security or Railroad Retirement Board disability benefit for 24 months.
·
You are a kidney dialysis or kidney transplant patient.
Medicare has two parts: ·
Part A (Hospital Insurance). Most people do not have to pay for Part A.
·
Part B (Medical Insurance). Most people pay monthly for Part B. Part A (Hospital Insurance)
Helps Pay For: Inpatient hospital care, care in critical access hospitals (small facilities that give limited outpatient and inpatient services to people in rural areas) and skilled nursing facilities, hospice care, and some home healthcare.
This section has been adapted from the Official U.S. Site for Medicare Information: http://www.medicare.gov/Basics/Overview.asp.
88
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Cost: Most people get Part A automatically when they turn age 65. You do not have to pay a monthly payment called a premium for Part A because you or a spouse paid Medicare taxes while you were working. If you (or your spouse) did not pay Medicare taxes while you were working and you are age 65 or older, you still may be able to buy Part A. If you are not sure you have Part A, look on your red, white, and blue Medicare card. It will show “Hospital Part A” on the lower left corner of the card. You can also call the Social Security Administration toll free at 1-800-772-1213 or call your local Social Security office for more information about buying Part A. If you get benefits from the Railroad Retirement Board, call your local RRB office or 1-800-808-0772. For more information, call your Fiscal Intermediary about Part A bills and services. The phone number for the Fiscal Intermediary office in your area can be obtained from the following Web site: http://www.medicare.gov/Contacts/home.asp. Part B (Medical Insurance) Helps Pay For: Doctors, services, outpatient hospital care, and some other medical services that Part A does not cover, such as the services of physical and occupational therapists, and some home healthcare. Part B helps pay for covered services and supplies when they are medically necessary. Cost: As of 2001, you pay the Medicare Part B premium of $50.00 per month. In some cases this amount may be higher if you did not choose Part B when you first became eligible at age 65. The cost of Part B may go up 10% for each 12-month period that you were eligible for Part B but declined coverage, except in special cases. You will have to pay the extra 10% cost for the rest of your life. Enrolling in Part B is your choice. You can sign up for Part B anytime during a 7-month period that begins 3 months before you turn 65. Visit your local Social Security office, or call the Social Security Administration at 1-800-7721213 to sign up. If you choose to enroll in Part B, the premium is usually taken out of your monthly Social Security, Railroad Retirement, or Civil Service Retirement payment. If you do not receive any of the above payments, Medicare sends you a bill for your part B premium every 3 months. You should receive your Medicare premium bill in the mail by the 10th of the month. If you do not, call the Social Security Administration at 1800-772-1213, or your local Social Security office. If you get benefits from the Railroad Retirement Board, call your local RRB office or 1-800-808-0772. For more information, call your Medicare carrier about bills and services. The
Your Rights and Insurance 169
phone number for the Medicare carrier in your area can be found at the following Web site: http://www.medicare.gov/Contacts/home.asp. You may have choices in how you get your healthcare including the Original Medicare Plan, Medicare Managed Care Plans (like HMOs), and Medicare Private Fee-for-Service Plans.
Medicaid Medicaid is a joint federal and state program that helps pay medical costs for some people with low incomes and limited resources. Medicaid programs vary from state to state. People on Medicaid may also get coverage for nursing home care and outpatient prescription drugs which are not covered by Medicare. You can find more information about Medicaid on the HCFA.gov Web site at http://www.hcfa.gov/medicaid/medicaid.htm. States also have programs that pay some or all of Medicare’s premiums and may also pay Medicare deductibles and coinsurance for certain people who have Medicare and a low income. To qualify, you must have: ·
Part A (Hospital Insurance),
·
Assets, such as bank accounts, stocks, and bonds that are not more than $4,000 for a single person, or $6,000 for a couple, and
·
A monthly income that is below certain limits.
For more information on these programs, look at the Medicare Savings Programs brochure, http://www.medicare.gov/Library/PDFNavigation/PDFInterim.asp?Langua ge=English&Type=Pub&PubID=10126. There are also Prescription Drug Assistance Programs available. Find information on these programs which offer discounts or free medications to individuals in need at http://www.medicare.gov/Prescription/Home.asp.
Financial Assistance for Cancer Care89 Cancer imposes heavy economic burdens on both patients and their families. For many people, a portion of medical expenses is paid by their health insurance plan. For individuals who do not have health insurance or who need financial assistance to cover health care costs, resources are available,
89
Adapted from the NCI: http://cis.nci.nih.gov/fact/8_3.htm.
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including government-sponsored programs and services supported by voluntary organizations. Cancer patients and their families should discuss any concerns they may have about health care costs with their physician, medical social worker, or the business office of their hospital or clinic. The organizations and resources listed below may offer financial assistance. Organizations that provide publications in Spanish or have Spanishspeaking staff have been identified. ·
The American Cancer Society (ACS) office can provide the telephone number of the local ACS office serving your area. The local ACS office may offer reimbursement for expenses related to cancer treatment including transportation, medicine, and medical supplies. The ACS also offers programs that help cancer patients, family members, and friends cope with the emotional challenges they face. Some publications are available in Spanish. Spanish-speaking staff are available. Telephone: 1– 800–ACS–2345 (1–800–227–2345). Web site: http://www.cancer.org
·
The AVONCares Program for Medically Underserved Women provides financial assistance and relevant education and support to low income, under- and uninsured, underserved women throughout the country in need of diagnostic and/or related services (transportation, child care, and social support) for the treatment of breast, cervical, and ovarian cancers. Telephone: 1–800–813–HOPE (1–800–813–4673). Web site: http://www.cancercare.org.
Community voluntary agencies and service organizations such as the Salvation Army, Lutheran Social Services, Jewish Social Services, Catholic Charities, and the Lions Club may offer help. These organizations are listed in your local phone directory. Some churches and synagogues may provide financial help or services to their members. Fundraising is another mechanism to consider. Some patients find that friends, family, and community members are willing to contribute financially if they are aware of a difficult situation. Contact your local library for information about how to organize fundraising efforts. General assistance programs provide food, housing, prescription drugs, and other medical expenses for those who are not eligible for other programs. Funds are often limited. Information can be obtained by contacting your state or local Department of Social Services; this number is found in the local telephone directory.
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Hill-Burton is a program through which hospitals receive construction funds from the Federal Government. Hospitals that receive Hill-Burton funds are required by law to provide some services to people who cannot afford to pay for their hospitalization. Information about which facilities are part of this program is available by calling the toll-free number or visiting the Web site shown below. A brochure about the program is available in Spanish. Telephone: 1–800–638–0742. Web site: http://www.hrsa.gov/osp/dfcr/obtain/consfaq.htm.
Income Tax Deductions Medical costs that are not covered by insurance policies sometimes can be deducted from annual income before taxes. Examples of tax deductible expenses might include mileage for trips to and from medical appointments, out-of-pocket costs for treatment, prescription drugs or equipment, and the cost of meals during lengthy medical visits. The local Internal Revenue Service office, tax consultants, or certified public accountants can determine medical costs that are tax deductible. These telephone numbers are available in the local telephone directory. Web site: http://www.irs.ustreas.gov.
The Patient Advocate Foundation The Patient Advocate Foundation (PAF) is a national nonprofit organization that provides education, legal counseling, and referrals to cancer patients and survivors concerning managed care, insurance, financial issues, job discrimination, and debt crisis matters. Telephone: 1–800–532–5274. Web site: http://www.patientadvocate.org. Patient Assistance Programs are offered by some pharmaceutical manufacturers to help pay for medications. To learn whether a specific drug might be available at reduced cost through such a program, talk with a physician or a medical social worker.
Transportation There are nonprofit organizations that arrange free or reduced cost air transportation for cancer patients going to or from cancer treatment centers. Financial need is not always a requirement. To find out about these programs, talk with a medical social worker. Ground transportation services
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may be offered or mileage reimbursed through the local ACS or your state or local Department of Social Services.
Veterans Benefits Eligible veterans and their dependents may receive cancer treatment at a Veterans Administration Medical Center. Treatment for service-connected conditions is provided, and treatment for other conditions may be available based on the veteran’s financial need. Some publications are available in Spanish. Spanish-speaking staff are available in some offices. Telephone: 1– 877–222–VETS. Web site: http://www.va.gov/vbs/health.
NORD’s Medication Assistance Programs Finally, the National Organization for Rare Disorders, Inc. (NORD) administers medication programs sponsored by humanitarian-minded pharmaceutical and biotechnology companies to help uninsured or underinsured individuals secure life-saving or life-sustaining drugs.90 NORD programs ensure that certain vital drugs are available “to those individuals whose income is too high to qualify for Medicaid but too low to pay for their prescribed medications.” The program has standards for fairness, equity, and unbiased eligibility. It currently covers some 14 programs for nine pharmaceutical companies. NORD also offers early access programs for investigational new drugs (IND) under the approved “Treatment INDs” programs of the Food and Drug Administration (FDA). In these programs, a limited number of individuals can receive investigational drugs that have yet to be approved by the FDA. These programs are generally designed for rare diseases or disorders. For more information, visit www.rarediseases.org.
Adapted from NORD: http://www.rarediseases.org/cgibin/nord/progserv#patient?id=rPIzL9oD&mv_pc=30.
90
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Additional Resources In addition to the references already listed in this chapter, you may need more information on health insurance, hospitals, or the healthcare system in general. The NIH has set up an excellent guidance Web site that addresses these and other issues. Topics include:91 ·
Health Insurance: http://www.nlm.nih.gov/medlineplus/healthinsurance.html
·
Health Statistics: http://www.nlm.nih.gov/medlineplus/healthstatistics.html
·
HMO and Managed Care: http://www.nlm.nih.gov/medlineplus/managedcare.html
·
Hospice Care: http://www.nlm.nih.gov/medlineplus/hospicecare.html
·
Medicaid: http://www.nlm.nih.gov/medlineplus/medicaid.html
·
Medicare: http://www.nlm.nih.gov/medlineplus/medicare.html
·
Nursing Homes and Long-term Care: http://www.nlm.nih.gov/medlineplus/nursinghomes.html
·
Patient’s Rights, Confidentiality, Informed Consent, Ombudsman Programs, Privacy and Patient Issues: http://www.nlm.nih.gov/medlineplus/patientissues.html
·
Veteran’s Health, Persian Gulf War, Gulf War Syndrome, Agent Orange: http://www.nlm.nih.gov/medlineplus/veteranshealth.html
Vocabulary Builder Doxorubicin: An anticancer drug that belongs to the family of drugs called antitumor antibiotics. It is an anthracycline. [NIH] Preclinical: Before a disease becomes clinically recognizable. [EU] Serum: The clear liquid part of the blood that remains after blood cells and clotting proteins have been removed. [NIH] You can access this information at: http://www.nlm.nih.gov/medlineplus/healthsystem.html.
91
Online Glossaries 175
ONLINE GLOSSARIES The Internet provides access to a number of free-to-use medical dictionaries and glossaries. The National Library of Medicine has compiled the following list of online dictionaries: ·
ADAM Medical Encyclopedia (A.D.A.M., Inc.), comprehensive medical reference: http://www.nlm.nih.gov/medlineplus/encyclopedia.html
·
MedicineNet.com Medical Dictionary (MedicineNet, Inc.): http://www.medterms.com/Script/Main/hp.asp
·
Merriam-Webster Medical Dictionary (Inteli-Health, Inc.): http://www.intelihealth.com/IH/
·
Multilingual Glossary of Technical and Popular Medical Terms in Eight European Languages (European Commission) - Danish, Dutch, English, French, German, Italian, Portuguese, and Spanish: http://allserv.rug.ac.be/~rvdstich/eugloss/welcome.html
·
On-line Medical Dictionary (CancerWEB): http://www.graylab.ac.uk/omd/
·
Technology Glossary (National Library of Medicine) - Health Care Technology: http://www.nlm.nih.gov/nichsr/ta101/ta10108.htm
·
Terms and Definitions (Office of Rare Diseases): http://rarediseases.info.nih.gov/ord/glossary_a-e.html
Beyond these, MEDLINEplus contains a very user-friendly encyclopedia covering every aspect of medicine (licensed from A.D.A.M., Inc.). The ADAM Medical Encyclopedia Web site address is http://www.nlm.nih.gov/medlineplus/encyclopedia.html. ADAM is also available on commercial Web sites such as drkoop.com (http://www.drkoop.com/) and Web MD (http://my.webmd.com/adam/asset/adam_disease_articles/a_to_z/a). Topics of interest can be researched by using keywords before continuing elsewhere, as these basic definitions and concepts will be useful in more advanced areas of research. You may choose to print various pages specifically relating to intraocular melanoma and keep them on file.
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Online Dictionary Directories The following are additional online directories compiled by the National Library of Medicine, including a number of specialized medical dictionaries and glossaries: ·
Medical Dictionaries: Medical & Biological (World Health Organization): http://www.who.int/hlt/virtuallibrary/English/diction.htm#Medical
·
MEL-Michigan Electronic Library List of Online Health and Medical Dictionaries (Michigan Electronic Library): http://mel.lib.mi.us/health/health-dictionaries.html
·
Patient Education: Glossaries (DMOZ Open Directory Project): http://dmoz.org/Health/Education/Patient_Education/Glossaries/
·
Web of Online Dictionaries (Bucknell University): http://www.yourdictionary.com/diction5.html#medicine
Glossary 177
INTRAOCULAR MELANOMA GLOSSARY The following is a complete glossary of terms used in this sourcebook. The definitions are derived from official public sources including the National Institutes of Health [NIH] and the European Union [EU]. After this glossary, we list a number of additional hardbound and electronic glossaries and dictionaries that you may wish to consult. Alum: A type of immune adjuvant (a substance used to help boost the immune response to a vaccine). Also called aluminum sulfate. [NIH] American Cancer Society: A voluntary organization concerned with the prevention and treatment of cancer through education and research. [NIH] Amifostine: A drug used as a chemoprotective drug to control some of the side effects of chemotherapy and radiation therapy. [NIH] Anaesthesia: Loss of feeling or sensation. Although the term is used for loss of tactile sensibility, or of any of the other senses, it is applied especially to loss of the sensation of pain, as it is induced to permit performance of surgery or other painful procedures. [EU] Analog: In chemistry, a substance that is similar, but not identical, to another. [NIH] Anemia: A condition in which the number of red blood cells is below normal. [NIH] Angiography: A procedure to x-ray blood vessels. The blood vessels can be seen because of an injection of a dye that shows up in the x-ray pictures. [NIH] Anthrax: An infectious bacterial zoonotic disease usually acquired by ingestion of Bacillus anthracis or its spores from infected pastures by herbivores or indirectly from infected carcasses by carnivores. It is transmitted to humans usually by contact with infected animals or their discharges (agricultural a.) or with contaminated animal products (industrial a.). Anthrax is classified by primary routes of inoculation as : cutaneous, gastrointestinal, and inhalational. Called also charbon, milzbrand and splenic fever. [EU] Antibiotic: A drug used to treat infections caused by bacteria and other microorganisms. [NIH] Antibody: A type of protein made by certain white blood cells in response to a foreign substance (antigen). Each antibody can bind to only a specific antigen. The purpose of this binding is to help destroy the antigen. Antibodies can work in several ways, depending on the nature of the antigen. Some antibodies destroy antigens directly. Others make it easier for
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white blood cells to destroy the antigen. [NIH] Arterial: Pertaining to an artery or to the arteries. [EU] Aspirin: A drug that reduces pain, fever, inflammation, and blood clotting. Aspirin belongs to the family of drugs called nonsteroidal anti-inflammatory agents. It is also being studied in cancer prevention. [NIH] Asymptomatic: Having no signs or symptoms of disease. [NIH] Azacitidine: An anticancer drug that belongs to the family of drugs called antimetabolites. [NIH] Benign: Not cancerous; does not invade nearby tissue or spread to other parts of the body. [NIH] Bereavement: Refers to the whole process of grieving and mourning and is associated with a deep sense of loss and sadness. [NIH] Biopsy: The removal of cells or tissues for examination under a microscope. When only a sample of tissue is removed, the procedure is called an incisional biopsy or core biopsy. When an entire tumor or lesion is removed, the procedure is called an excisional biopsy. When a sample of tissue or fluid is removed with a needle, the procedure is called a needle biopsy or fineneedle aspiration. [NIH] Brachytherapy: A procedure in which radioactive material sealed in needles, seeds, wires, or catheters is placed directly into or near a tumor. Also called internal radiation, implant radiation, or interstitial radiation therapy. [NIH] Busulfan: An anticancer drug that belongs to the family of drugs called alkylating agents. [NIH] Cannula: A tube for insertion into a duct or cavity; during insertion its lumen is usually occupied by a trocar. [EU] Carboplatin: An anticancer drug that belongs to the family of drugs called platinum compounds. [NIH] Carcinogenic: Producing carcinoma. [EU] Carcinoma: Cancer that begins in the skin or in tissues that line or cover internal organs. [NIH] Cardiac: Having to do with the heart. [NIH] Cell: The individual unit that makes up all of the tissues of the body. All living things are made up of one or more cells. [NIH] Cervical: Relating to the neck, or to the neck of any organ or structure. Cervical lymph nodes are located in the neck; cervical cancer refers to cancer of the uterine cervix, which is the lower, narrow end (the "neck") of the uterus. [NIH]
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Charities: Social welfare organizations with programs designed to assist individuals in times of need. [NIH] Chemoprotective: A quality of some drugs used in cancer treatment. Chemoprotective agents protect healthy tissue from the toxic effects of anticancer drugs. [NIH] Chemotherapy: Treatment with anticancer drugs. [NIH] Choroid: The thin, highly vascular membrane covering most of the posterior of the eye between the retina and sclera. [NIH] Chronic: A disease or condition that persists or progresses over a long period of time. [NIH] Cisplatin: An anticancer drug that belongs to the family of drugs called platinum compounds. [NIH] CNS: Central nervous system. The brain and spinal cord. [NIH] Cobalt: A trace element that is a component of vitamin B12. It has the atomic symbol Co, atomic number 27, and atomic weight 58.93. It is used in nuclear weapons, alloys, and pigments. Deficiency in animals leads to anemia; its excess in humans can lead to erythrocytosis. [NIH] Contralateral: Having to do with the opposite side of the body. [NIH] Cornea: The transparent part of the eye that covers the iris and the pupil and allows light to enter the inside. [NIH] CSF: Cerebrospinal fluid. The fluid flowing around the brain and spinal cord. CSF is produced in the ventricles of the brain. [NIH] Curative: Tending to overcome disease and promote recovery. [EU] Cutaneous: Having to do with the skin. [NIH] Dacarbazine: An anticancer drug that belongs to the family of drugs called alkylating agents. [NIH] Dermatology: A medical specialty concerned with the skin, its structure, functions, diseases, and treatment. [NIH] Difluoromethylornithine: DFMO. An anticancer drug that has been shown to reduce the risk of cancer in animals. [NIH] Doxorubicin: An anticancer drug that belongs to the family of drugs called antitumor antibiotics. It is an anthracycline. [NIH] Embolization: The blocking of an artery by a clot or foreign material. Embolization can be done as treatment to block the flow of blood to a tumor. [NIH]
Encapsulated: Confined to a specific, localized area and surrounded by a thin layer of tissue. [NIH] Enzyme: A protein that speeds up chemical reactions in the body. [NIH]
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Epidermal: Pertaining to or resembling epidermis. Called also epidermic or epidermoid. [EU] Epithelial: Refers to the cells that line the internal and external surfaces of the body. [NIH] Exophthalmos: Abnormal protrusion of the eyeball; called also proptosis. [EU]
Extraction: The process or act of pulling or drawing out. [EU] Filgrastim: A colony-stimulating factor that stimulates the production of neutrophils (a type of white blood cell). It is a cytokine that belongs to the family of drugs called hematopoietic (blood-forming) agents. Also called granulocyte colony-stimulating factor (G-CSF). [NIH] Flavopiridol: Belongs to the family of anticancer drugs called flavinols. [NIH] Fundus: The larger part of a hollow organ that is farthest away from the organ's opening. The bladder, gallbladder, stomach, uterus, eye, and cavity of the middle ear all have a fundus. [NIH] Gonioscopy: Examination of the angle of the anterior chamber of the eye with the gonioscope. [EU] Granulocytopenia: A deficiency in the number of granulocytes, a type of white blood cell. [NIH] Hematogenous: bloodstream. [NIH]
Originating in the blood or spread through the
Hemorrhage: Bleeding or escape of blood from a vessel. [NIH] Hepatic: Refers to the liver. [NIH] Hormones: Chemicals produced by glands in the body and circulated in the bloodstream. Hormones control the actions of certain cells or organs. [NIH] Hyphema: Bleeding in the anterior chamber of the eye. [NIH] Hypotensive: Characterized by or causing diminished tension or pressure, as abnormally low blood pressure. [EU] Immunization: The induction of immunity. [EU] Implantation: The insertion or grafting into the body of biological, living, inert, or radioactive material. [EU] Incision: A cut made in the body during surgery. [NIH] Interferon: A biological response modifier (a substance that can improve the body's natural response to disease). Interferons interfere with the division of cancer cells and can slow tumor growth. There are several types of interferons, including interferon-alpha, -beta, and -gamma. These substances are normally produced by the body. They are also made in the laboratory for use in treating cancer and other diseases. [NIH]
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Intraocular: Within the eye. [EU] Intrathecal: Describes the fluid-filled space between the thin layers of tissue that cover the brain and spinal cord. Drugs can be injected into the fluid or a sample of the fluid can be removed for testing. [NIH] Invasive: 1. having the quality of invasiveness. 2. involving puncture or incision of the skin or insertion of an instrument or foreign material into the body; said of diagnostic techniques. [EU] Iodine: A nonmetallic element of the halogen group that is represented by the atomic symbol I, atomic number 53, and atomic weight of 126.90. It is a nutritionally essential element, especially important in thyroid hormone synthesis. In solution, it has anti-infective properties and is used topically. [NIH]
Irinotecan: An anticancer drug that belongs to a family of anticancer drugs called topoisomerase inhibitors. It is a camptothecin analogue. Also called CPT 11. [NIH] Iris: The most anterior portion of the uveal layer, separating the anterior chamber from the posterior. It consists of two layers - the stroma and the pigmented epithelium. Color of the iris depends on the amount of melanin in the stroma on reflection from the pigmented epithelium. [NIH] Irrigation: Washing by a stream of water or other fluid. [EU] Lenses: Pieces of glass or other transparent materials used for magnification or increased visual acuity. [NIH] Leukemia: Cancer of blood-forming tissue. [NIH] Levofloxacin: A substance used to treat bacterial infections. It belongs to the family of drugs called quinolone antibiotics. [NIH] Liposomal: A drug preparation that contains the active drug in very tiny fat particles. This fat-encapsulated drug is absorbed better, and its distribution to the tumor site is improved. [NIH] Liver: A large, glandular organ located in the upper abdomen. The liver cleanses the blood and aids in digestion by secreting bile. [NIH] Lymphoma: Cancer that arises in cells of the lymphatic system. [NIH] Malignant: Cancerous; a growth with a tendency to invade and destroy nearby tissue and spread to other parts of the body. [NIH] Mammogram: An x-ray of the breast. [NIH] Mammography: The use of x-rays to create a picture of the breast. [NIH] Melanocytes: Cells in the skin that produce and contain the pigment called melanin. [NIH] Melanoma: A form of skin cancer that arises in melanocytes, the cells that produce pigment. Melanoma usually begins in a mole. [NIH]
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Metastasis: The spread of cancer from one part of the body to another. Tumors formed from cells that have spread are called "secondary tumors" and contain cells that are like those in the original (primary) tumor. The plural is metastases. [NIH] Metastasize: To spread from one part of the body to another. When cancer cells metastasize and form secondary tumors, the cells in the metastatic tumor are like those in the original (primary) tumor. [NIH] Metastatic: Having to do with metastasis, which is the spread of cancer from one part of the body to another. [NIH] Microscopy: The application of microscope magnification to the study of materials that cannot be properly seen by the unaided eye. [NIH] Millimeter: A measure of length. A millimeter is approximately 26-times smaller than an inch. [NIH] Molecular: Of, pertaining to, or composed of molecules : a very small mass of matter. [EU] Myeloma: Cancer that arises in plasma cells, a type of white blood cell. [NIH] Neoplasm: A new growth of benign or malignant tissue. [NIH] Neuroblastoma: Cancer that arises in immature nerve cells and affects mostly infants and children. [NIH] Oncologist: A doctor who specializes in treating cancer. Some oncologists specialize in a particular type of cancer treatment. For example, a radiation oncologist specializes in treating cancer with radiation. [NIH] Oncology: The study of cancer. [NIH] Ophthalmic: Pertaining to the eye. [EU] Ophthalmology: A surgical specialty concerned with the structure and function of the eye and the medical and surgical treatment of its defects and diseases. [NIH] Orbital: Pertaining to the orbit (= the bony cavity that contains the eyeball). [EU]
Palliative: 1. affording relief, but not cure. 2. an alleviating medicine. [EU] Pap test: The collection of cells from the cervix for examination under a microscope. It is used to detect changes that may be cancer or may lead to cancer, and can show noncancerous conditions, such as infection or inflammation. Also called a Pap smear. [NIH] Particle: A tiny mass of material. [EU] Peptide: Any compound consisting of two or more amino acids, the building blocks of proteins. Peptides are combined to make proteins. [NIH] Periorbital: Situated around the orbit, or eye socket. [EU]
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Phenylbutyrate: An anticancer drug that belongs to the family of drugs called differentiating agents. [NIH] Plasmapheresis: The process of separating certain cells from the plasma in the blood by a machine; only the cells are returned to the person. Plasmapheresis can be used to remove excess antibodies from the blood. [NIH] Posterior: Situated in back of, or in the back part of, or affecting the back or dorsal surface of the body. In lower animals, it refers to the caudal end of the body. [EU] Preclinical: Before a disease becomes clinically recognizable. [EU] Progressive: Advancing; going forward; going from bad to worse; increasing in scope or severity. [EU] Proptosis: Forward projection or displacement especially of the eyeball : exophthalmos. [EU] Prostate: A gland in males that surrounds the neck of the bladder and the urethra. It secretes a substance that liquifies coagulated semen. It is situated in the pelvic cavity behind the lower part of the pubic symphysis, above the deep layer of the triangular ligament, and rests upon the rectum. [NIH] Proteins: Polymers of amino acids linked by peptide bonds. The specific sequence of amino acids determines the shape and function of the protein. [NIH]
Pupil: The aperture in the iris through which light passes. [NIH] Pyrazoloacridine: An anticancer drug that belongs to the family of drugs called acridines. [NIH] Radioactive: Giving off radiation. [NIH] Radioisotope: An unstable element that releases radiation as it breaks down. Radioisotopes can be used in imaging tests or as a treatment for cancer. [NIH] Radiolabeled: Any compound that has been joined with a radioactive substance. [NIH] Radiology: The use of radiation (such as x-rays) or other imaging technologies (such as ultrasound and magnetic resonance imaging) to diagnose or treat disease. [NIH] Radiotherapy: The treatment of disease by ionizing radiation. [EU] Radium: Radium. A radioactive element of the alkaline earth series of metals. It has the atomic symbol Ra, atomic number 88, and atomic weight 226. Radium is the product of the disintegration of uranium and is present in pitchblende and all ores containing uranium. It is used clinically as a source of beta and gamma-rays in radiotherapy, particularly brachytherapy. [NIH] Randomized: Describes an experiment or clinical trial in which animal or
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human subjects are assigned by chance to separate groups that compare different treatments. [NIH] Rebeccamycin: An anticancer drug that belongs to the family of drugs called antineoplastic antibiotics. [NIH] Receptor: A molecule inside or on the surface of a cell that binds to a specific substance and causes a specific physiologic effect in the cell. [NIH] Recurrence: The return of cancer, at the same site as the original (primary) tumor or in another location, after the tumor had disappeared. [NIH] Refractory: Not readily yielding to treatment. [EU] Regimen: A treatment plan that specifies the dosage, the schedule, and the duration of treatment. [NIH] Resection: Removal of tissue or part or all of an organ by surgery. [NIH] Retina: The ten-layered nervous tissue membrane of the eye. It is continuous with the optic nerve and receives images of external objects and transmits visual impulses to the brain. Its outer surface is in contact with the choroid and the inner surface with the vitreous body. The outer-most layer is pigmented, whereas the inner nine layers are transparent. [NIH] Retinoblastoma: An eye cancer that most often occurs in children younger than 5 years. It occurs in hereditary and nonhereditary (sporadic) forms. [NIH] Sarcoma: A cancer of the bone, cartilage, fat, muscle, blood vessels or other connective or supportive tissue. [NIH] Sargramostim: A colony-stimulating factor that stimulates the production of blood cells, especially platelets, during chemotherapy. It is a cytokine that belongs to the family of drugs called hematopoietic (blood-forming) agents. Also called GM-CSF. [NIH] Screening: Checking for disease when there are no symptoms. [NIH] Serum: The clear liquid part of the blood that remains after blood cells and clotting proteins have been removed. [NIH] Staging: Performing exams and tests to learn the extent of the cancer within the body, especially whether the disease has spread from the original site to other parts of the body. [NIH] STI571: A drug that is being studied for its ability to inhibit the growth of certain cancers. It interferes with a portion of the protein produced by the bcr/abl oncogene. [NIH] Subconjunctival: Situated or occurring beneath the conjunctiva. [EU] Subcutaneous: Beneath the skin. [NIH] Systemic: Affecting the entire body. [NIH] Temozolomide: An anticancer drug that belongs to the family of drugs
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called alkylating agents. [NIH] Testicular: Pertaining to a testis. [EU] Thalidomide: A drug that belongs to the family of drugs called angiogenesis inhibitors. It prevents the growth of new blood vessels into a solid tumor. [NIH] Thiotepa: An anticancer drug that belongs to the family of drugs called alkylating agents. [NIH] Topotecan: An anticancer drug that belongs to the family drugs called topoisomerase inhibitors. [NIH] Transplantation: person. [NIH]
The replacement of an organ with one from another
Ultrasonography: A procedure in which sound waves (called ultrasound) are bounced off tissues and the echoes are converted to a picture (sonogram). [NIH]
Unresectable: Unable to be surgically removed. [NIH] Urine: Fluid containing water and waste products. Urine is made by the kidneys, stored in the bladder, and leaves the body through the urethra. [NIH] Uveitis: An inflammation of part or all of the uvea, the middle (vascular) tunic of the eye, and commonly involving the other tunics (the sclera and cornea, and the retina). [EU] Vaccination: Treatment with a vaccine. [NIH] Vaccine: A substance or group of substances meant to cause the immune system to respond to a tumor or to microorganisms, such as bacteria or viruses. [NIH] Vitreous: Glasslike or hyaline; often used alone to designate the vitreous body of the eye (corpus vitreum). [EU]
General Dictionaries and Glossaries While the above glossary is essentially complete, the dictionaries listed here cover virtually all aspects of medicine, from basic words and phrases to more advanced terms (sorted alphabetically by title; hyperlinks provide rankings, information and reviews at Amazon.com): ·
The Cancer Dictionary by Roberta Altman, Michael J., Md Sarg; Paperback - 368 pages, 2nd Revised edition (November 1999), Checkmark Books; ISBN: 0816039542; http://www.amazon.com/exec/obidos/ASIN/0816039542/icongroupinterna
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·
Dictionary of Medical Acronymns & Abbreviations by Stanley Jablonski (Editor), Paperback, 4th edition (2001), Lippincott Williams & Wilkins Publishers, ISBN: 1560534605, http://www.amazon.com/exec/obidos/ASIN/1560534605/icongroupinterna
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Dictionary of Medical Terms : For the Nonmedical Person (Dictionary of Medical Terms for the Nonmedical Person, Ed 4) by Mikel A. Rothenberg, M.D, et al, Paperback - 544 pages, 4th edition (2000), Barrons Educational Series, ISBN: 0764112015, http://www.amazon.com/exec/obidos/ASIN/0764112015/icongroupinterna
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A Dictionary of the History of Medicine by A. Sebastian, CD-Rom edition (2001), CRC Press-Parthenon Publishers, ISBN: 185070368X, http://www.amazon.com/exec/obidos/ASIN/185070368X/icongroupinterna
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Dorland’s Illustrated Medical Dictionary (Standard Version) by Dorland, et al, Hardcover - 2088 pages, 29th edition (2000), W B Saunders Co, ISBN: 0721662544, http://www.amazon.com/exec/obidos/ASIN/0721662544/icongroupinterna
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Dorland’s Electronic Medical Dictionary by Dorland, et al, Software, 29th Book & CD-Rom edition (2000), Harcourt Health Sciences, ISBN: 0721694934, http://www.amazon.com/exec/obidos/ASIN/0721694934/icongroupinterna
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Dorland’s Pocket Medical Dictionary (Dorland’s Pocket Medical Dictionary, 26th Ed) Hardcover - 912 pages, 26th edition (2001), W B Saunders Co, ISBN: 0721682812, http://www.amazon.com/exec/obidos/ASIN/0721682812/icongroupinterna /103-4193558-7304618
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Melloni’s Illustrated Medical Dictionary (Melloni’s Illustrated Medical Dictionary, 4th Ed) by Melloni, Hardcover, 4th edition (2001), CRC PressParthenon Publishers, ISBN: 85070094X, http://www.amazon.com/exec/obidos/ASIN/85070094X/icongroupinterna
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Stedman’s Electronic Medical Dictionary Version 5.0 (CD-ROM for Windows and Macintosh, Individual) by Stedmans, CD-ROM edition (2000), Lippincott Williams & Wilkins Publishers, ISBN: 0781726328, http://www.amazon.com/exec/obidos/ASIN/0781726328/icongroupinterna
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Stedman’s Medical Dictionary by Thomas Lathrop Stedman, Hardcover 2098 pages, 27th edition (2000), Lippincott, Williams & Wilkins, ISBN: 068340007X, http://www.amazon.com/exec/obidos/ASIN/068340007X/icongroupinterna
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Stedman’s Oncology Words by Beverly J. Wolpert (Editor), Stedmans; Paperback - 502 pages, 3rd edition (June 15, 2000), Lippincott, Williams &
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Wilkins; ISBN: 0781726549; http://www.amazon.com/exec/obidos/ASIN/0781726549/icongroupinterna ·
Tabers Cyclopedic Medical Dictionary (Thumb Index) by Donald Venes (Editor), et al, Hardcover - 2439 pages, 19th edition (2001), F A Davis Co., ISBN: 0803606540, http://www.amazon.com/exec/obidos/ASIN/0803606540/icongroupinterna
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INDEX A Alum ......................................................65 Amifostine..............................................51 Anaesthesia...........................................96 Analog ...................................................62 Anemia ..................................54, 131, 179 Angiography ........................113, 114, 117 Antibody.....................59, 60, 85, 112, 177 Arterial ...................................................96 Asymptomatic ......................114, 115, 119 Azacitidine .............................................52 B Benign ...............4, 87, 111, 112, 113, 182 Bereavement .........................................34 Biopsy..............................68, 85, 113, 178 Brachytherapy ...........................67, 92, 99 Busulfan.................................................54 C Carboplatin ............................................55 Carcinoma .............................66, 114, 178 Cardiac ..................................................68 Cell .......11, 51, 56, 57, 60, 75, 86, 87, 96, 100, 101, 103, 110, 111, 113, 117, 121, 127, 180, 182, 184 Cervical....................33, 45, 111, 170, 178 Chemoprotective ...........................85, 177 Chemotherapy ..... 35, 50, 51, 52, 53, 54, 55, 56, 57, 58, 60, 61, 62, 63, 64, 66, 67, 69, 75, 76, 85, 87, 177, 184 Choroid .....4, 5, 11, 12, 13, 15, 59, 61, 64, 65, 66, 110, 111, 112, 114, 115, 116, 117, 120, 120 Chronic ................................113, 127, 160 Cisplatin.................................................62 Cobalt ..........................................115, 118 Contralateral ........................................101 Cornea .....................4, 13, 14, 64, 88, 185 Curative .................................................35 Cutaneous ...............24, 97, 101, 112, 177 D Dacarbazine ..........................................95 Difluoromethylornithine..........................99 E Embolization ........................................117 Encapsulated.........................86, 120, 181 Enzyme..................................................57 Epidermal ............................................100 Epithelial ..........................................50, 59 Exophthalmos......................101, 103, 183 F Filgrastim ...............................................62
Flavopiridol............................................ 56 Fundus ........................................ 131, 180 G Gonioscopy ......................................... 113 Granulocytopenia.................................. 59 H Hematogenous ........................... 101, 111 Hemorrhage ................................ 114, 117 Hepatic........................................ 101, 112 Hyphema............................................. 113 Hypotensive .......................................... 96 I Implantation ........................................ 101 Incision.......................................... 86, 181 Interferon......................... 63, 86, 102, 180 Intrathecal ............................................. 54 Invasive............................................... 141 Iodine .......................... 115, 116, 117, 119 Irinotecan .............................................. 57 Iris .. 11, 12, 13, 14, 15, 24, 25, 59, 61, 63, 64, 65, 66, 110, 111, 112, 113, 114, 132, 179, 181, 183 L Leukemia ... 50, 52, 53, 54, 56, 57, 58, 59, 60, 61, 62, 66, 67, 69, 127 Levofloxacin .......................................... 58 Liposomal.............................................. 59 Liver ...... 51, 52, 55, 56, 63, 87, 103, 111, 113, 180, 181 Lymphoma .... 50, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 66, 67, 69, 127 M Malignant ... 4, 11, 50, 53, 87, 94, 99, 112, 113, 114, 117, 118, 119, 120, 127, 182 Mammography...................................... 32 Melanocytes............................ 11, 25, 181 Metastasis.. 87, 95, 96, 99, 100, 101, 111, 113, 182 Metastasize................. 112, 114, 132, 182 Metastatic..... 52, 55, 61, 66, 68, 101, 102, 112, 114, 115, 132, 182 Millimeter....................................... 25, 182 Molecular ............................ 122, 125, 126 Myeloma ............................. 56, 59, 60, 69 N Neoplasm........................................ 4, 113 Neuroblastoma ..................................... 52 O Oncologist ..................................... 45, 182 Oncology............................................... 17 Ophthalmic............................ 92, 115, 117
Index 189
Orbital ............................15, 101, 120, 120 P Palliative ................................................35 Particle...........................................92, 118 Peptide ..............................66, 68, 87, 183 Periorbital ..............................................99 Phenylbutyrate.......................................52 Plasmapheresis .....................................68 Posterior ...24, 25, 94, 110, 112, 113, 115, 116, 117, 118, 119, 119, 120, 179, 181 Postoperative...............................117, 120 Preclinical ............................................142 Preoperative ..................67, 117, 119, 120 Proptosis................................97, 103, 180 Prostate .........................................35, 127 Proteins ...........68, 87, 143, 173, 182, 184 Pupil...............................24, 114, 117, 179 Pyrazoloacridine ....................................61 R Radioactive.....85, 92, 103, 115, 119, 132, 178, 180, 183 Radiolabeled........................................112 Radiotherapy .........92, 103, 118, 120, 183 Randomized ........................116, 119, 120 Rebeccamycin .......................................62 Receptor ..............................................100 Recurrence ..................................110, 121 Refractory ............................53, 54, 56, 58
Regimen.............................. 54, 59, 66, 69 Resection ................................ 96, 98, 118 Retina.................... 4, 11, 64, 88, 113, 185 Retinoblastoma............................. 93, 127 S Sarcoma.................. 50, 51, 52, 55, 56, 60 Sargramostim ................................. 65, 66 Screening............................ 35, 73, 75, 78 Staging.................................................. 12 Subconjunctival................................... 111 Subcutaneous ..................................... 111 Systemic ............................................. 110 T Temozolomide ................................ 63, 64 Testicular ...................... 51, 55, 57, 58, 59 Thalidomide .......................................... 64 Thiotepa .......................................... 55, 58 Topotecan ............................................. 55 Transplantation ....... 51, 54, 55, 56, 57, 60 U Unresectable....................................... 114 Urine ..................................................... 68 Uveitis ........................................... 64, 113 V Vaccination ........................................... 68 Vaccine ... 59, 65, 66, 68, 85, 88, 177, 185 Vitreous........................... 64, 88, 113, 185
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